Vitamin D DeficiencyNCT04939636
Vitamin D Supplementation in Estonian Conscripts
A study testing Vitamin D3 capsules 4000IU/100µg. and Vitamin D3 capsules 600IU/15µg. in people with Vitamin D Deficiency and Military Activity, run by Tartu University Hospital at 1 site in Estonia.
Trial summary
A longitudinal, double-blinded, randomized, trial, with a 10 month follow-up period will be conducted between July 2021 to May 2022 Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency, Military Activity, Physical Stress
- What is being tested?
- Vitamin D3 capsules 4000IU/100µg. and Vitamin D3 capsules 600IU/15µg.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteEstonia
- Study dates
- 19 Jul 2021to 16 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participating in military service at the Estonian Defence Forces
- Voluntary participation in the study
Who cannot join
- Refusal of a conscript or withdrawal of consent
- Departure from military unit
- Force majeure
- Acute trauma or illness in the course of conscript requiring hospital treatment
- Serious side effects or allergies to vitamin D capsules
Trial locations and contacts
1 site in 1 country.
Estonia1 site
Kuperjanov Infantry Battalion, Estonian Defence Forces
Võru, Võrumaa, 50400
About this study
Official title: The Influence of Vitamin D on the Physical Performance and General Health of Conscripts of the Estonian Defence Forces
A longitudinal, double-blinded, randomized, trial, with a 10 month follow-up period will be conducted between July 2021 to May 2022
Read the detailed description
I DETAILED DESCRIPTION OF THE SUBJECTS AND THEIR RECRUITMENT Four hundred volunteers from the 2nd Infantry Brigade of the Kuperjanov Infantry Battalion (Võru, Estonia) aged 18-30 are invited to participate in this study. To this end, a general meeting will be held at the beginning of the conscription. The participants will be given an overview of the study, its objectives and methods, all the risks that may be involved, and the potential benefits. The meeting will emphasise the voluntary nature of the study and the fact that non-participation in the study does not lead to changes in the overall cost of their conscription. Conscripts wishing to participate in the study can sign an information sheet and informed consent form to participate in the study after the meeting. Based on previous studies (experience of our working group in 2014-2017), the participation of about 150-170 conscripts is expected (25-30% of the total number).
Places of the study:
- University of Tartu Clinic, Sports Medicine and Rehabilitation Clinic, Sports Traumatology Centre, Puusepa 1a, Tartu, 51014
- Recruitment of subjects, general medical assessment and completion of questionnaires, blood sampling, physical tests, and bone densitometry analysis. Kuperjanov Infantry Battalion, 2nd Infantry Brigade (Kose tee 3a, 65603, Võru)
- Determination of vitamin D, PTH, and Ca in the blood: Synlab Eesti OÜ, Teguri 37b, 50107, Tartu
The questionnaires used in the study will be completed on site at the Kuperjanov Infantry Battalion. The subjects are divided into two groups by a computer with double-blind randomisation in a 1 : 1 ratio - subjects receiving 4,000 IU of vitamin D or a 100 µg capsule (Group I, n = 75-85) and subjects receiving 600 IU or 15 µg vitamin D capsules (Group II, n = 75-85) of the same shape and colour once a day with breakfast The corresponding capsules are pre-prepared in agreement with the manufacturer (HC CLOVER Productos y Servicios, S.Lk) and packed in standard jars (100 capsules per jar; a total of three jars with the corresponding number of capsules for ten months should be used for the study). Each jar is coded individually for each subject in accordance with the randomised groups.
Serum levels of vitamin D (25(OH)D), s-PTH, s-Ca, and s-iCa are determined in all subjects during the visits (SynLab Eesti OÜ, Tartu). Analyses are taken four times during the study (visits): July, October, February, and April/May. All analyses are determined at the end of the study at the same time to reduce intra-assay variability due to the use of different kits.
For all health-related problems related to the study, as well as other problems related to the study, conscripts are consulted by the orthopaedist in charge (Dr Leho Rips). If there are any health problems not related to the study, the medical staff of Kuperjanov will inform the principal researcher (Dr Leho Rips). The subjects have the right to contact the principal researcher directly in case of problems related to the study.
Exclusion from the study: - refusal of a conscript or withdrawal of consent, departure from military unit, force majeure, acute trauma, or illness in the course of conscript requiring hospital treatment. All these cases are recorded and taken into account in the subsequent analysis.
II DETAILED DESCRIPTION OF THE STUDY METHODOLOGY
Anthropometric measurements. The length of the body (LB) is measured with a metal anthropometer in a vertical position, the heels are together and the person measuring the subject ensures that the lower eyelid and the outer ear canal of the subject are in a horizontal plane. To determine body weight (W), the subject should wear as little clothes as possible. An electronic scale with a measuring accuracy of ± 0,1 kg is used for the measurement. The formula BMI = W / LB [kg/m2] is used to calculate the body mass index.
Vitamin D in serum ((25(OH)D is determined by chemiluminescence immunoassay (CLIA). (LIAISON 25 OH Vitamin D TOTAL Assay (REF 310600, DiaSorin Inc, USA)) with a sensitivity of 4 ng/ml and an intra-assay variability coefficient (CV) of 0.1-3.8%. Vitamin D levels in the blood are determined four times during the study period to explain the effects of strain, Estonian climate, and supplementation on serum concentrations (at the beginning of the conscript, twice in the middle of the conscript, and in the final phase).
Calcium (s-Ca), ionised calcium (s-iCa), and parathyroid hormone (s-PTH) are determined from blood serum by potentiometry and chemiluminescent immunoassay (CLIA), respectively.
All blood tests are taken at the same time in the morning before breakfast and during the same periods, analogously to vitamin D.
About 5 to 8 ml of blood is taken during each blood test, a total of 20 to 32 ml. This is about 2 tablespoons of blood throughout the study.
Assessment of knee pain. The visual analogue scale VAS is used where '0' - no pain and '10' - maximum pain, associated with the KOOS questionnaire to assess subjective complaints related to the knee joint.
Subjective assessment of knee joint function by the subject. The subjects evaluate the subjective complaints and function of the knee joint with a questionnaire (Knee Injury and Osteoarthritis Outcome Score, KOOS), which is used to find out their assessment of the condition of their knee(s) and how well they can cope with daily activities. It is possible to get a maximum of 100 points (no complaints) and a minimum of 0 points, which means extreme complaints.
Hand grip strength is determined by isometric contraction while standing, upper limb away from the body, using a hand dynamometer (Lafayette Instrument Co., USA). The studies use maximal hand grip strength as an indirect indicator of whole-body muscle strength.
Subjective assessment of physical activity by the subject. The Baecke Physical Activity Questionnaire consists of three parts and is based on a person's subjective assessment of their work, sport, and leisure (it is possible to get 1-5 points for each question). To interpret the results, the number of points in each subsection and the total number of points in the whole questionnaire are given. A similar questionnaire has been used to determine physical activity in previous studies in conscripts. IPAQ International Physical Activity Questionnaire, which assesses the level of physical activity in the last 7 days.
The assessment of subjective pain in different regions of the body is done with the Cornell Musculoskeletal Discomfort Questionnaires (CMDQ), where the intensity of pain and the region of the body can be noted. Pain questionnaire ( to assess pain in different regions of the body on a scale from 0 (none) to 10 (maximum possible pain).
The assessment of subjective health status and health-related quality of life by the subject is performed using standard questionnaires SF-36, RAND36, and BDI - Beck Depression Inventory. The questionnaires have been validated in Estonia and are valid for identifying health-related aspects. The questionnaires are based on the subject's assessment of their health aspects. The SF-36 questionnaire identifies the health status with a descriptive health profile and is more sensitive than other questionnaires. It also calculates the total physical and mental health scores. The BDI questionnaire is based on the assessment of the subject concerning aspects related to their mental health.
Evaluation of emotional well-being and somatic symptom disorder symptoms on the basis of the EEK-2 emotional well-being questionnaire and ACR 2010 questionnaires The emotional well-being questionnaire is a patient-completed self-assessment scale for identifying major depression and anxiety disorders and their adjacent symptoms in the past month. The EEK-2 questionnaire consists of 28 statements formulated based on diagnostic criteria and clinical feasibility. The answers are on a scale of 0-4 and the subject indicates how much the problem has disturbed them in the last month. The ACR 2010 questionnaire is a questionnaire developed and validated by the American College of Rheumatology to assess the presence of the somatic symptom disorder and non-physical pain (such as fibromyalgia) in subjects.
Fitness tests. Along with other data, the level of physical training of the conscripts is analysed using the standardised Army Physical Fitness Test (APFT), consisting of push-ups, sit-ups, and a 2-mile (3.2-km) run. The test has been adapted and used for a long time in the Estonian Defence Forces. Based on the results, the total score is calculated.
Bone density study or densitometry. A mobile DXL machine is used to determine bone density. Bone density is determined from the heel bone. Bone density is determined twice during the study period on site. Bone density measurement of the heel bone is performed by densitometry with a DXL Calscan instrument (Demetech AB, SWE). The measurements are performed at the beginning of the study and after about 10 months, just before the end of the conscript. The procedure shows the bone density of the subjects. The second study provides an assessment of the effects of exercise on the musculoskeletal system.
Health status monitoring. The health status of conscripts is monitored in the medical centre of the Combat Service Support Battalion of the 2nd Infantry Brigade, where records are made of the appeals and complaints of the conscripts, the number of days in inpatient care and bed rest, and the number of days when a conscript was absent from the conscript due to health problems.
Evaluation of vitamin D content in food rations of the Defence Forces. The average daily vitamin D content of the 1-month period of conscription in the daily food ration for conscripts is assessed. Based on international analytical data on vitamin D content in food.
Questionnaire completion and data collection, blood sampling, anthropometric evaluations, and health monitoring are performed by the study team.
- Conditions
- Vitamin D Deficiency, Military Activity, Physical Stress
- Being tested
- Vitamin D3 capsules 4000IU/100µg., Vitamin D3 capsules 600IU/15µg.
- Keywords
- Vitamin D supplementation, Conscripts, Military sevice, Physical preformance
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3 capsules 4000IU/100µg.Dietary supplement
Vitamin D3 supplementation
Vitamin D3 capsules 600IU/15µg.Dietary supplement
Vitamin D3 supplementation
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D3 capsules 4000IU/100µg | Active comparator | Get Vitamin D3 capsules 4000IU/100µg. Receives: Dietary Supplement: Vitamin D3 capsules 4000IU/100µg. |
| Vitamin D3 capsules 600IU/15µg | Active comparator | Get Vitamin D3 capsules 600IU/15µg. Receives: Dietary Supplement: Vitamin D3 capsules 600IU/15µg. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of vitamin D between study groups (Baseline, no intervention)
Prevalence of vitamin D measured serum vitamin D 25(OH)D concentration. Vitamin D considered as sufficient if the serum 25(OH)D concentration is ≥75 nmol/L, insufficient if <75 nmol/L, deficient if <50 nmol/L and critical deficiency < 25 nmol/L.
Measured: 0 months Baseline
Prevalence of vitamin D between study groups (Intervention I vs.II)
Prevalence of vitamin D measured serum vitamin D 25(OH)D concentration. Vitamin D considered as sufficient if the serum 25(OH)D concentration is ≥75 nmol/L, insufficient if <75 nmol/L, deficient if <50 nmol/L and critical deficiency < 25 nmol/L.
Measured: 3 months
Prevalence of vitamin D between study groups (Intervention I vs.II)
Prevalence of vitamin D measured serum vitamin D 25(OH)D concentration. Vitamin D considered as sufficient if the serum 25(OH)D concentration is ≥75 nmol/L, insufficient if <75 nmol/L, deficient if <50 nmol/L and critical deficiency < 25 nmol/L.
Measured: app.6-7 months
Prevalence of vitamin D between study groups (Intervention I vs.II)
Prevalence of vitamin D measured serum vitamin D 25(OH)D concentration. Vitamin D considered as sufficient if the serum 25(OH)D concentration is ≥75 nmol/L, insufficient if <75 nmol/L, deficient if <50 nmol/L and critical deficiency < 25 nmol/L.
Measured: app. 9-10 months
Secondary outcomes (61)
Serum parathyroid hormone
Serum parathyroid hormone concentration (pmol/l)
Measured: 0 months baseline
Serum parathyroid hormone
Serum parathyroid hormone concentration (pmol/l)
Measured: 3 months
Serum parathyroid hormone
Serum parathyroid hormone concentration (pmol/l)
Measured: app. 6-7 months
Serum parathyroid hormone
Serum parathyroid hormone concentration (pmol/l)
Measured: app. 9-10 months
Serum calcium
Serum calcium (Ca) concentration (mmol/l)
Measured: 0 months baseline
Serum calcium
Serum calcium (Ca) concentration (mmol/l)
Measured: 3 months
Serum calcium
Serum calcium (Ca) concentration (mmol/l)
Measured: app.6-7 months
Serum calcium
Serum calcium (Ca) concentration (mmol/l)
Measured: app. 9-10 months
Serum ionized calcium
Serum ionized calcium (Ca-i) concentration (mmol/l)
Measured: 0 months baseline
Serum ionized calcium
Serum ionized calcium (Ca-i) concentration (mmol/l)
Measured: app. 3 months
Serum ionized calcium
Serum ionized calcium (Ca-i) concentration (mmol/l)
Measured: app.6-7 months
Serum ionized calcium
Serum ionized calcium (Ca-i) concentration (mmol/l)
Measured: app.9-10 months
Knee pain The visual analogue scale VAS
To assess subjective complaints related to the knee joint. The visual analogue scale VAS is used where '0' - no pain and '10' - maximum pain
Measured: 0 months baseline
Knee pain The visual analogue scale VAS
To assess subjective complaints related to the knee joint. The visual analogue scale VAS is used where '0' - no pain and '10' - maximum pain
Measured: 3 months
Knee pain The visual analogue scale VAS
To assess subjective complaints related to the knee joint. The visual analogue scale VAS is used where '0' - no pain and '10' - maximum pain
Measured: app. 6-7 months
Knee pain The visual analogue scale VAS
To assess subjective complaints related to the knee joint. The visual analogue scale VAS is used where '0' - no pain and '10' - maximum pain
Measured: app.9-10 months
Subjective assessment of knee joint function KOOS
The subjects evaluate the subjective complaints and function of the knee joint with a questionnaire. It is possible to get a maximum of 100 points (no complaints) and a minimum of 0 points, which means extreme complaints.
Measured: 0 months baseline
Subjective assessment of knee joint function KOOS
The subjects evaluate the subjective complaints and function of the knee joint with a questionnaire. It is possible to get a maximum of 100 points (no complaints) and a minimum of 0 points, which means extreme complaints.
Measured: 3 months
Subjective assessment of knee joint function KOOS
The subjects evaluate the subjective complaints and function of the knee joint with a questionnaire. It is possible to get a maximum of 100 points (no complaints) and a minimum of 0 points, which means extreme complaints.
Measured: app. 6-7 months
Subjective assessment of knee joint function KOOS
The subjects evaluate the subjective complaints and function of the knee joint with a questionnaire. It is possible to get a maximum of 100 points (no complaints) and a minimum of 0 points, which means extreme complaints.
Measured: app. 9-10 months
Hand grip strength
Is determined by isometric contraction while standing, upper limb away from the body, using a hand dynamometer (Lafayette Instrument Co., USA)
Measured: 0 months baseline
Hand grip strength
Is determined by isometric contraction while standing, upper limb away from the body, using a hand dynamometer (Lafayette Instrument Co., USA)
Measured: 3 months
Hand grip strength
Is determined by isometric contraction while standing, upper limb away from the body, using a hand dynamometer (Lafayette Instrument Co., USA)
Measured: app.6-7 months
Hand grip strength
Is determined by isometric contraction while standing, upper limb away from the body, using a hand dynamometer (Lafayette Instrument Co., USA)
Measured: app.9-10 months
Subjective assessment of physical activity by the subject (Baeckley).
The Baecke Physical Activity Questionnaire consists of three parts and is based on a person's subjective assessment of their work, sport, and leisure. Each domain could receive a score from one to five points, thus allowing a total score from three (minimum) to fifteen (maximum).
Measured: 0 months baseline
Subjective assessment of physical activity by the subject (IPAQ).
International Physical Activity Questionnaire, which assesses the level of physical activity in the last 7 days. Categorical Score- three levels of physical activity are presented - low, medium and high.
Measured: 0 months baseline
Subjective assessment of physical activity by the subject (IPAQ).
International Physical Activity Questionnaire, which assesses the level of physical activity in the last 7 days. Categorical Score- three levels of physical activity are presented - low, medium and high.
Measured: 3 months
Subjective assessment of physical activity by the subject (IPAQ).
International Physical Activity Questionnaire, which assesses the level of physical activity in the last 7 days. Categorical Score- three levels of physical activity are presented - low, medium and high.
Measured: app. 6-7 months
Subjective assessment of physical activity by the subject (IPAQ).
International Physical Activity Questionnaire, which assesses the level of physical activity in the last 7 days. Categorical Score- three levels of physical activity are presented - low, medium and high.
Measured: app. 9-10 months
The assessment of subjective pain in different regions of the body (Cornell)
Is done with the Cornell Musculoskeletal Discomfort Questionnaires where the intensity of pain and the region of the body can be noted as 'mild', 'moderate' and 'severe discomfort'.
Measured: 0 months baseline
The assessment of subjective pain in different regions of the body (Cornell)
Is done with the Cornell Musculoskeletal Discomfort Questionnaires where the intensity of pain and the region of the body can be noted as 'mild', 'moderate' and 'severe discomfort'
Measured: 3 months
The assessment of subjective pain in different regions of the body (Cornell)
Is done with the Cornell Musculoskeletal Discomfort Questionnaires where the intensity of pain and the region of the body can be noted as 'mild', 'moderate' and 'severe discomfort'.
Measured: app. 6-7 months
The assessment of subjective pain in different regions of the body (Cornell)
Is done with the Cornell Musculoskeletal Discomfort Questionnaires where the intensity of pain and the region of the body can be noted as 'mild', 'moderate' and 'severe discomfort'.
Measured: app.9-10 months
Pain questionnaire
To assess pain in different regions of the body on a scale from 0 (none) to 10 (maximum possible pain)
Measured: 0 months baseline
Pain questionnaire
To assess pain in different regions of the body on a scale from 0 (none) to 10 (maximum possible pain)
Measured: 3 months
Pain questionnaire
To assess pain in different regions of the body on a scale from 0 (none) to 10 (maximum possible pain)
Measured: app. 6-7 months
Pain questionnaire
To assess pain in different regions of the body on a scale from 0 (none) to 10 (maximum possible pain)
Measured: app. 9-10 months
The assessment of subjective health status and health-related quality of life by the subject-RAND-36.
Is performed using standard questionnaires RAND 36. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
Measured: 0 months baseline
The assessment of subjective health status and health-related quality of life by the subject- RAND-36.
Is performed using standard questionnaires RAND 36. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
Measured: 3 months
The assessment of subjective health status and health-related quality of life by the subject- RAND-36.
Is performed using standard questionnaires RAND 36. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
Measured: app.6-7 months
The assessment of subjective health status and health-related quality of life by the subject- RAND 36.
Is performed using standard questionnaires RAND 36. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
Measured: app.9-10 months
The assessment of subjective health status and health-related quality of life by the subject - Beck Depression
Is performed using standard questionnaires - Beck Depression Inventory. The BDI questionnaire is based on the assessment of the subject concerning aspects related to their mental health. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe depression.
Measured: 0 months - baselilne
The assessment of subjective health status and health-related quality of life by the subject - Beck Depression
Is performed using standard questionnaires - Beck Depression Inventory. The BDI questionnaire is based on the assessment of the subject concerning aspects related to their mental health. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe depression.
Measured: 3 months
The assessment of subjective health status and health-related quality of life by the subject - Beck Depression
Is performed using standard questionnaires - Beck Depression Inventory. The BDI questionnaire is based on the assessment of the subject concerning aspects related to their mental health. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe depression.
Measured: app. 6-7 months
The assessment of subjective health status and health-related quality of life by the subject - Beck Depression
Is performed using standard questionnaires - Beck Depression Inventory. The BDI questionnaire is based on the assessment of the subject concerning aspects related to their mental health. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe depression.
Measured: app. 9-10 months
Evaluation of emotional well-being and somatic symptom disorder symptoms - EEK-2
On the basis of the EEK-2 emotional well-being questionnaire. The emotional well-being questionnaire is a patient-completed self-assessment scale for identifying major depression and anxiety disorders and their adjacent symptoms in the past month. The EEK-2 questionnaire consists of 28 statements formulated based on diagnostic criteria and clinical feasibility. The answers are on a scale of 0-4 and the subject indicates how much the problem has disturbed them in the last month.
Measured: 0 months baseline
Evaluation of emotional well-being and somatic symptom disorder symptoms - EEK-2
On the basis of the EEK-2 emotional well-being questionnaire.The emotional well-being questionnaire is a patient-completed self-assessment scale for identifying major depression and anxiety disorders and their adjacent symptoms in the past month. The EEK-2 questionnaire consists of 28 statements formulated based on diagnostic criteria and clinical feasibility. The answers are on a scale of 0-4 and the subject indicates how much the problem has disturbed them in the last month.
Measured: 3 months baseline
Evaluation of emotional well-being and somatic symptom disorder symptoms- EEK-2.
On the basis of the EEK-2 emotional well-being questionnaire.The emotional well-being questionnaire is a patient-completed self-assessment scale for identifying major depression and anxiety disorders and their adjacent symptoms in the past month. The EEK-2 questionnaire consists of 28 statements formulated based on diagnostic criteria and clinical feasibility. The answers are on a scale of 0-4 and the subject indicates how much the problem has disturbed them in the last month.
Measured: app. 6-7 months
Evaluation of emotional well-being and somatic symptom disorder symptoms -EEK-2
On the basis of the EEK-2 emotional well-being questionnaire.The emotional well-being questionnaire is a patient-completed self-assessment scale for identifying major depression and anxiety disorders and their adjacent symptoms in the past month. The EEK-2 questionnaire consists of 28 statements formulated based on diagnostic criteria and clinical feasibility. The answers are on a scale of 0-4 and the subject indicates how much the problem has disturbed them in the last month.
Measured: app.9-10 months
Evaluation of emotional well-being and somatic symptom disorder symptoms - ACR 2010
The ACR 2010 questionnaire is a questionnaire developed and validated by the American College of Rheumatology to assess the presence of the somatic symptom disorder and non-physical pain (such as fibromyalgia) in subjects. Pain score 0 no pain and 19 maximum pain. Symptoms score 0 - no symptoms and 12 maximum symptoms.
Measured: 0 months - baseline
Evaluation of emotional well-being and somatic symptom disorder symptoms ACR 2010
The ACR 2010 questionnaire is a questionnaire developed and validated by the American College of Rheumatology to assess the presence of the somatic symptom disorder and non-physical pain (such as fibromyalgia) in subjects. Pain score 0 no pain and 19 maximum pain. Symptoms score 0 - no symptoms and 12 maximum symptoms.
Measured: 3 months
Evaluation of emotional well-being and somatic symptom disorder symptoms ACR 2010
The ACR 2010 questionnaire is a questionnaire developed and validated by the American College of Rheumatology to assess the presence of the somatic symptom disorder and non-physical pain (such as fibromyalgia) in subjects. Pain score 0 no pain and 19 maximum pain. Symptoms score 0 - no symptoms and 12 maximum symptoms.
Measured: app. 6-7 months
Evaluation of emotional well-being and somatic symptom disorder symptoms ACR 2010
The ACR 2010 questionnaire is a questionnaire developed and validated by the American College of Rheumatology to assess the presence of the somatic symptom disorder and non-physical pain (such as fibromyalgia) in subjects. Pain score 0 no pain and 19 maximum pain. Symptoms score 0 - no symptoms and 12 maximum symptoms.
Measured: app. 9-10 months
Fitness tests
the level of physical training of the conscripts is analysed using the standardised Army Physical Fitness Test (APFT). Soldiers were scored based on their performance in three events consisting of the push-up, sit-up, and a two-mile run, ranging from 0 to 100 points in each event. A minimum score of 60 in each event was required to pass the test. The soldier's overall score was the sum of the points from the three events. If a soldier passed all three events, the total could have range from 180 to 300.
Measured: 0 months baseline
Fitness tests
the level of physical training of the conscripts is analysed using the standardised Army Physical Fitness Test (APFT). Soldiers were scored based on their performance in three events consisting of the push-up, sit-up, and a two-mile run, ranging from 0 to 100 points in each event. A minimum score of 60 in each event was required to pass the test. The soldier's overall score was the sum of the points from the three events. If a soldier passed all three events, the total could have range from 180 to 300.
Measured: app 5 months
Fitness tests
the level of physical training of the conscripts is analysed using the standardised Army Physical Fitness Test (APFT). Soldiers were scored based on their performance in three events consisting of the push-up, sit-up, and a two-mile run, ranging from 0 to 100 points in each event. A minimum score of 60 in each event was required to pass the test. The soldier's overall score was the sum of the points from the three events. If a soldier passed all three events, the total could have range from 180 to 300.
Measured: app 9-10 months
Bone density study or densitometry
A mobile DXL machine is used to determine bone density
Measured: 0 months baseline
Bone density study or densitometry
A mobile DXL machine is used to determine bone density
Measured: app.9-10 months
Health status monitoring - upper respiratory tract infections (UTRI)
The health status of conscripts is monitored in the medical centre of the Combat Service Support Battalion of the 2nd Infantry Brigade, where records are made of the appeals and complaints of the conscripts, the number of days in inpatient care and bed rest, and the number of days when a conscript was absent from the conscript due to upper respiratory infection (UTRI).
Measured: During all the study (daily 0-10 months)
Health status monitoring - musculoskeletal injury
The health status of conscripts is monitored in the medical centre of the Combat Service Support Battalion of the 2nd Infantry Brigade, where records are made of the appeals and complaints of the conscripts, the number of days in inpatient care and bed rest, and the number of days when a conscript was absent from the conscript due to musculoskeletal injury.
Measured: During all the study (daily 0-10 months)
Bone density study or densitometry
A mobile DXL machine is used to determine bone density
Measured: app. 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2021
- Study start19 Jul 2021
- Primary completion16 Jun 2022
- Study completion16 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Triple blinded randomized placebo-controlled study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tartu University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Estonian Defence Forces, University of Tartu
- Responsible party
- Principal investigator, Leho Rips, Tartu University Hospital
- Investigators
- Madis Rahu, PhD, Study director, University of Tartu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04939636
- Sponsor's protocol ID
- 323/T-3
- Status last verified
- Dec 2022
- First submitted
- 13 Oct 2020
- Last updated
- 28 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Baecke JA, Burema J, Frijters JE. A short questionnaire for the measurement of habitual physical activity in epidemiological studies. Am J Clin Nutr. 1982 Nov;36(5):936-42. doi: 10.1093/ajcn/36.5.936.
PubMed 7137077Bischoff-Ferrari HA, Giovannucci E, Willett WC, Dietrich T, Dawson-Hughes B. Estimation of optimal serum concentrations of 25-hydroxyvitamin D for multiple health outcomes. Am J Clin Nutr. 2006 Jul;84(1):18-28. doi: 10.1093/ajcn/84.1.18.
PubMed 16825677Dawson-Hughes B, Heaney RP, Holick MF, Lips P, Meunier PJ, Vieth R. Estimates of optimal vitamin D status. Osteoporos Int. 2005 Jul;16(7):713-6. doi: 10.1007/s00198-005-1867-7. Epub 2005 Mar 18.
PubMed 15776217EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Turck D, Bresson JL, Burlingame B, Dean T, Fairweather-Tait S, Heinonen M, Hirsch-Ernst KI, Mangelsdorf I, McArdle HJ, Naska A, Nowicka G, Pentieva K, Sanz Y, Siani A, Sjodin A, Stern M, Tome D, Van Loveren H, Vinceti M, Willatts P, Lamberg-Allardt C, Przyrembel H, Tetens I, Dumas C, Fabiani L, Ioannidou S, Neuhauser-Berthold M. Dietary reference values for vitamin K. EFSA J. 2017 May 22;15(5):e04780. doi: 10.2903/j.efsa.2017.4780. eCollection 2017 May.
PubMed 32625486Goodman GP, Schoenfeld AJ, Owens BD, Dutton JR, Burks R, Belmont PJ. Non-emergent orthopaedic injuries sustained by soldiers in Operation Iraqi Freedom. J Bone Joint Surg Am. 2012 Apr 18;94(8):728-35. doi: 10.2106/JBJS.K.00129.
PubMed 22517389Hughes JM, Smith MA, Henning PC, Scofield DE, Spiering BA, Staab JS, Hydren JR, Nindl BC, Matheny RW Jr. Bone formation is suppressed with multi-stressor military training. Eur J Appl Physiol. 2014 Nov;114(11):2251-9. doi: 10.1007/s00421-014-2950-6. Epub 2014 Jul 16.
PubMed 25027064Hypponen E, Power C. Hypovitaminosis D in British adults at age 45 y: nationwide cohort study of dietary and lifestyle predictors. Am J Clin Nutr. 2007 Mar;85(3):860-8. doi: 10.1093/ajcn/85.3.860.
PubMed 17344510Inklebarger J, Griffin M, Taylor MJ, Dembry RB. Femoral and tibial stress fractures associated with vitamin D insufficiency. J R Army Med Corps. 2014 Mar;160(1):61-3. doi: 10.1136/jramc-2013-000085. Epub 2013 Jun 26.
PubMed 24109098Knapik JJ, East WB. History of United States Army physical fitness and physical readiness training. US Army Med Dep J. 2014 Apr-Jun:5-19.
PubMed 24706237Kull M Jr, Kallikorm R, Tamm A, Lember M. Seasonal variance of 25-(OH) vitamin D in the general population of Estonia, a Northern European country. BMC Public Health. 2009 Jan 19;9:22. doi: 10.1186/1471-2458-9-22.
PubMed 19152676Laaksi IT, Ruohola JP, Ylikomi TJ, Auvinen A, Haataja RI, Pihlajamaki HK, Tuohimaa PJ. Vitamin D fortification as public health policy: significant improvement in vitamin D status in young Finnish men. Eur J Clin Nutr. 2006 Aug;60(8):1035-8. doi: 10.1038/sj.ejcn.1602414. Epub 2006 Feb 15.
PubMed 16482069Laaksi I, Ruohola JP, Tuohimaa P, Auvinen A, Haataja R, Pihlajamaki H, Ylikomi T. An association of serum vitamin D concentrations < 40 nmol/L with acute respiratory tract infection in young Finnish men. Am J Clin Nutr. 2007 Sep;86(3):714-7. doi: 10.1093/ajcn/86.3.714.
PubMed 17823437Laaksi I, Ruohola JP, Mattila V, Auvinen A, Ylikomi T, Pihlajamaki H. Vitamin D supplementation for the prevention of acute respiratory tract infection: a randomized, double-blinded trial among young Finnish men. J Infect Dis. 2010 Sep 1;202(5):809-14. doi: 10.1086/654881. No abstract available.
PubMed 20632889Li-Ng M, Aloia JF, Pollack S, Cunha BA, Mikhail M, Yeh J, Berbari N. A randomized controlled trial of vitamin D3 supplementation for the prevention of symptomatic upper respiratory tract infections. Epidemiol Infect. 2009 Oct;137(10):1396-404. doi: 10.1017/S0950268809002404. Epub 2009 Mar 19.
PubMed 19296870Maloney SR, Almarines D, Goolkasian P. Vitamin D levels and monospot tests in military personnel with acute pharyngitis: a retrospective chart review. PLoS One. 2014 Jul 10;9(7):e101180. doi: 10.1371/journal.pone.0101180. eCollection 2014.
PubMed 25009977
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Vitamin D on the Physical Performance and General Health of Conscripts of the Estonian Defence Forces
- ClinicalTrials.gov ID
- NCT04939636
- Acronym / sponsor ID
- 323/T-3
- Conditions
- Vitamin D Deficiency, Military Activity, Physical Stress
- Keywords
- Vitamin D supplementation, Conscripts, Military sevice, Physical preformance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Tartu University HospitalUniversity, hospital or other
- Collaborators
- Estonian Defence Forces, University of Tartu
- Study start
- 19 Jul 2021 (actual)
- Primary completion
- 16 Jun 2022 (actual)
- Study completion
- 16 Jun 2022 (actual)
- First posted
- 25 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A longitudinal, double-blinded, randomized, trial, with a 10 month follow-up period will be conducted between July 2021 to May 2022
Detailed description
I DETAILED DESCRIPTION OF THE SUBJECTS AND THEIR RECRUITMENT Four hundred volunteers from the 2nd Infantry Brigade of the Kuperjanov Infantry Battalion (Võru, Estonia) aged 18-30 are invited to participate in this study. To this end, a general meeting will be held at the beginning of the conscription. The participants will be given an overview of the study, its objectives and methods, all the risks that may be involved, and the potential benefits. The meeting will emphasise the voluntary nature of the study and the fact that non-participation in the study does not lead to changes in the overall cost of their conscription. Conscripts wishing to participate in the study can sign an information sheet and informed consent form to participate in the study after the meeting. Based on previous studies (experience of our working group in 2014-2017), the participation of about 150-170 conscripts is expected (25-30% of the total number).
Places of the study:
- University of Tartu Clinic, Sports Medicine and Rehabilitation Clinic, Sports Traumatology Centre, Puusepa 1a, Tartu, 51014
- Recruitment of subjects, general medical assessment and completion of questionnaires, blood sampling, physical tests, and bone densitometry analysis. Kuperjanov Infantry Battalion, 2nd Infantry Brigade (Kose tee 3a, 65603, Võru)
- Determination of vitamin D, PTH, and Ca in the blood: Synlab Eesti OÜ, Teguri 37b, 50107, Tartu
The questionnaires used in the study will be completed on site at the Kuperjanov Infantry Battalion. The subjects are divided into two groups by a computer with double-blind randomisation in a 1 : 1 ratio - subjects receiving 4,000 IU of vitamin D or a 100 µg capsule (Group I, n = 75-85) and subjects receiving 600 IU or 15 µg vitamin D capsules (Group II, n = 75-85) of the same shape and colour once a day with breakfast The corresponding capsules are pre-prepared in agreement with the manufacturer (HC CLOVER Productos y Servicios, S.Lk) and packed in standard jars (100 capsules per jar; a total of three jars with the corresponding number of capsules for ten months should be used for the study). Each jar is coded individually for each subject in accordance with the randomised groups.
Serum levels of vitamin D (25(OH)D), s-PTH, s-Ca, and s-iCa are determined in all subjects during the visits (SynLab Eesti OÜ, Tartu). Analyses are taken four times during the study (visits): July, October, February, and April/May. All analyses are determined at the end of the study at the same time to reduce intra-assay variability due to the use of different kits.
For all health-related problems related to the study, as well as other problems related to the study, conscripts are consulted by the orthopaedist in charge (Dr Leho Rips). If there are any health problems not related to the study, the medical staff of Kuperjanov will inform the principal researcher (Dr Leho Rips). The subjects have the right to contact the principal researcher directly in case of problems related to the study.
Exclusion from the study: - refusal of a conscript or withdrawal of consent, departure from military unit, force majeure, acute trauma, or illness in the course of conscript requiring hospital treatment. All these cases are recorded and taken into account in the subsequent analysis.
II DETAILED DESCRIPTION OF THE STUDY METHODOLOGY
Anthropometric measurements. The length of the body (LB) is measured with a metal anthropometer in a vertical position, the heels are together and the person measuring the subject ensures that the lower eyelid and the outer ear canal of the subject are in a horizontal plane. To determine body weight (W), the subject should wear as little clothes as possible. An electronic scale with a measuring accuracy of ± 0,1 kg is used for the measurement. The formula BMI = W / LB [kg/m2] is used to calculate the body mass index.
Vitamin D in serum ((25(OH)D is determined by chemiluminescence immunoassay (CLIA). (LIAISON 25 OH Vitamin D TOTAL Assay (REF 310600, DiaSorin Inc, USA)) with a sensitivity of 4 ng/ml and an intra-assay variability coefficient (CV) of 0.1-3.8%. Vitamin D levels in the blood are determined four times during the study period to explain the effects of strain, Estonian climate, and supplementation on serum concentrations (at the beginning of the conscript, twice in the middle of the conscript, and in the final phase).
Calcium (s-Ca), ionised calcium (s-iCa), and parathyroid hormone (s-PTH) are determined from blood serum by potentiometry and chemiluminescent immunoassay (CLIA), respectively.
All blood tests are taken at the same time in the morning before breakfast and during the same periods, analogously to vitamin D.
About 5 to 8 ml of blood is taken during each blood test, a total of 20 to 32 ml. This is about 2 tablespoons of blood throughout the study.
Assessment of knee pain. The visual analogue scale VAS is used where '0' - no pain and '10' - maximum pain, associated with the KOOS questionnaire to assess subjective complaints related to the knee joint.
Subjective assessment of knee joint function by the subject. The subjects evaluate the subjective complaints and function of the knee joint with a questionnaire (Knee Injury and Osteoarthritis Outcome Score, KOOS), which is used to find out their assessment of the condition of their knee(s) and how well they can cope with daily activities. It is possible to get a maximum of 100 points (no complaints) and a minimum of 0 points, which means extreme complaints.
Hand grip strength is determined by isometric contraction while standing, upper limb away from the body, using a hand dynamometer (Lafayette Instrument Co., USA). The studies use maximal hand grip strength as an indirect indicator of whole-body muscle strength.
Subjective assessment of physical activity by the subject. The Baecke Physical Activity Questionnaire consists of three parts and is based on a person's subjective assessment of their work, sport, and leisure (it is possible to get 1-5 points for each question). To interpret the results, the number of points in each subsection and the total number of points in the whole questionnaire are given. A similar questionnaire has been used to determine physical activity in previous studies in conscripts. IPAQ International Physical Activity Questionnaire, which assesses the level of physical activity in the last 7 days.
The assessment of subjective pain in different regions of the body is done with the Cornell Musculoskeletal Discomfort Questionnaires (CMDQ), where the intensity of pain and the region of the body can be noted. Pain questionnaire ( to assess pain in different regions of the body on a scale from 0 (none) to 10 (maximum possible pain).
The assessment of subjective health status and health-related quality of life by the subject is performed using standard questionnaires SF-36, RAND36, and BDI - Beck Depression Inventory. The questionnaires have been validated in Estonia and are valid for identifying health-related aspects. The questionnaires are based on the subject's assessment of their health aspects. The SF-36 questionnaire identifies the health status with a descriptive health profile and is more sensitive than other questionnaires. It also calculates the total physical and mental health scores. The BDI questionnaire is based on the assessment of the subject concerning aspects related to their mental health.
Evaluation of emotional well-being and somatic symptom disorder symptoms on the basis of the EEK-2 emotional well-being questionnaire and ACR 2010 questionnaires The emotional well-being questionnaire is a patient-completed self-assessment scale for identifying major depression and anxiety disorders and their adjacent symptoms in the past month. The EEK-2 questionnaire consists of 28 statements formulated based on diagnostic criteria and clinical feasibility. The answers are on a scale of 0-4 and the subject indicates how much the problem has disturbed them in the last month. The ACR 2010 questionnaire is a questionnaire developed and validated by the American College of Rheumatology to assess the presence of the somatic symptom disorder and non-physical pain (such as fibromyalgia) in subjects.
Fitness tests. Along with other data, the level of physical training of the conscripts is analysed using the standardised Army Physical Fitness Test (APFT), consisting of push-ups, sit-ups, and a 2-mile (3.2-km) run. The test has been adapted and used for a long time in the Estonian Defence Forces. Based on the results, the total score is calculated.
Bone density study or densitometry. A mobile DXL machine is used to determine bone density. Bone density is determined from the heel bone. Bone density is determined twice during the study period on site. Bone density measurement of the heel bone is performed by densitometry with a DXL Calscan instrument (Demetech AB, SWE). The measurements are performed at the beginning of the study and after about 10 months, just before the end of the conscript. The procedure shows the bone density of the subjects. The second study provides an assessment of the effects of exercise on the musculoskeletal system.
Health status monitoring. The health status of conscripts is monitored in the medical centre of the Combat Service Support Battalion of the 2nd Infantry Brigade, where records are made of the appeals and complaints of the conscripts, the number of days in inpatient care and bed rest, and the number of days when a conscript was absent from the conscript due to health problems.
Evaluation of vitamin D content in food rations of the Defence Forces. The average daily vitamin D content of the 1-month period of conscription in the daily food ration for conscripts is assessed. Based on international analytical data on vitamin D content in food.
Questionnaire completion and data collection, blood sampling, anthropometric evaluations, and health monitoring are performed by the study team.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Triple blinded randomized placebo-controlled study
| Arm | Type | Receives |
|---|---|---|
| Vitamin D3 capsules 4000IU/100µg | Active comparator | Dietary Supplement: Vitamin D3 capsules 4000IU/100µg.Get Vitamin D3 capsules 4000IU/100µg. |
| Vitamin D3 capsules 600IU/15µg | Active comparator | Dietary Supplement: Vitamin D3 capsules 600IU/15µg.Get Vitamin D3 capsules 600IU/15µg. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Participating in military service at the Estonian Defence Forces
- Voluntary participation in the study
Key exclusion criteria (5 listed)
- Refusal of a conscript or withdrawal of consent
- Departure from military unit
- Force majeure
- Acute trauma or illness in the course of conscript requiring hospital treatment
- Serious side effects or allergies to vitamin D capsules
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D3 capsules 4000IU/100µg.Vitamin D3 supplementation | Dietary supplement | Vitamin D3 capsules 4000IU/100µg |
| Vitamin D3 capsules 600IU/15µg.Vitamin D3 supplementation | Dietary supplement | Vitamin D3 capsules 600IU/15µg |
Primary outcome
Prevalence of vitamin D between study groups (Baseline, no intervention)
Time frame: 0 months Baseline
Prevalence of vitamin D measured serum vitamin D 25(OH)D concentration. Vitamin D considered as sufficient if the serum 25(OH)D concentration is ≥75 nmol/L, insufficient if <75 nmol/L, deficient if <50 nmol/L and critical deficiency < 25 nmol/L.
Prevalence of vitamin D between study groups (Intervention I vs.II)
Time frame: 3 months
Prevalence of vitamin D measured serum vitamin D 25(OH)D concentration. Vitamin D considered as sufficient if the serum 25(OH)D concentration is ≥75 nmol/L, insufficient if <75 nmol/L, deficient if <50 nmol/L and critical deficiency < 25 nmol/L.
Prevalence of vitamin D between study groups (Intervention I vs.II)
Time frame: app.6-7 months
Prevalence of vitamin D measured serum vitamin D 25(OH)D concentration. Vitamin D considered as sufficient if the serum 25(OH)D concentration is ≥75 nmol/L, insufficient if <75 nmol/L, deficient if <50 nmol/L and critical deficiency < 25 nmol/L.
Prevalence of vitamin D between study groups (Intervention I vs.II)
Time frame: app. 9-10 months
Prevalence of vitamin D measured serum vitamin D 25(OH)D concentration. Vitamin D considered as sufficient if the serum 25(OH)D concentration is ≥75 nmol/L, insufficient if <75 nmol/L, deficient if <50 nmol/L and critical deficiency < 25 nmol/L.
61 secondary outcomes
Serum parathyroid hormone
Time frame: 0 months baseline
Serum parathyroid hormone
Time frame: 3 months
Serum parathyroid hormone
Time frame: app. 6-7 months
Serum parathyroid hormone
Time frame: app. 9-10 months
Serum calcium
Time frame: 0 months baseline
Serum calcium
Time frame: 3 months
Serum calcium
Time frame: app.6-7 months
Serum calcium
Time frame: app. 9-10 months
Serum ionized calcium
Time frame: 0 months baseline
Serum ionized calcium
Time frame: app. 3 months
Serum ionized calcium
Time frame: app.6-7 months
Serum ionized calcium
Time frame: app.9-10 months
Knee pain The visual analogue scale VAS
Time frame: 0 months baseline
Knee pain The visual analogue scale VAS
Time frame: 3 months
Knee pain The visual analogue scale VAS
Time frame: app. 6-7 months
Knee pain The visual analogue scale VAS
Time frame: app.9-10 months
Subjective assessment of knee joint function KOOS
Time frame: 0 months baseline
Subjective assessment of knee joint function KOOS
Time frame: 3 months
Subjective assessment of knee joint function KOOS
Time frame: app. 6-7 months
Subjective assessment of knee joint function KOOS
Time frame: app. 9-10 months
Hand grip strength
Time frame: 0 months baseline
Hand grip strength
Time frame: 3 months
Hand grip strength
Time frame: app.6-7 months
Hand grip strength
Time frame: app.9-10 months
Subjective assessment of physical activity by the subject (Baeckley).
Time frame: 0 months baseline
Subjective assessment of physical activity by the subject (IPAQ).
Time frame: 0 months baseline
Subjective assessment of physical activity by the subject (IPAQ).
Time frame: 3 months
Subjective assessment of physical activity by the subject (IPAQ).
Time frame: app. 6-7 months
Subjective assessment of physical activity by the subject (IPAQ).
Time frame: app. 9-10 months
The assessment of subjective pain in different regions of the body (Cornell)
Time frame: 0 months baseline
The assessment of subjective pain in different regions of the body (Cornell)
Time frame: 3 months
The assessment of subjective pain in different regions of the body (Cornell)
Time frame: app. 6-7 months
The assessment of subjective pain in different regions of the body (Cornell)
Time frame: app.9-10 months
Pain questionnaire
Time frame: 0 months baseline
Pain questionnaire
Time frame: 3 months
Pain questionnaire
Time frame: app. 6-7 months
Pain questionnaire
Time frame: app. 9-10 months
The assessment of subjective health status and health-related quality of life by the subject-RAND-36.
Time frame: 0 months baseline
The assessment of subjective health status and health-related quality of life by the subject- RAND-36.
Time frame: 3 months
The assessment of subjective health status and health-related quality of life by the subject- RAND-36.
Time frame: app.6-7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2022.
- Background: PubMed 7137077Baecke JA, Burema J, Frijters JE. A short questionnaire for the measurement of habitual physical activity in epidemiological studies. Am J Clin Nutr. 1982 Nov;36(5):936-42. doi: 10.1093/ajcn/36.5.936.
- Background: PubMed 16825677Bischoff-Ferrari HA, Giovannucci E, Willett WC, Dietrich T, Dawson-Hughes B. Estimation of optimal serum concentrations of 25-hydroxyvitamin D for multiple health outcomes. Am J Clin Nutr. 2006 Jul;84(1):18-28. doi: 10.1093/ajcn/84.1.18.
- Background: PubMed 15776217Dawson-Hughes B, Heaney RP, Holick MF, Lips P, Meunier PJ, Vieth R. Estimates of optimal vitamin D status. Osteoporos Int. 2005 Jul;16(7):713-6. doi: 10.1007/s00198-005-1867-7. Epub 2005 Mar 18.
- Background: PubMed 32625486EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Turck D, Bresson JL, Burlingame B, Dean T, Fairweather-Tait S, Heinonen M, Hirsch-Ernst KI, Mangelsdorf I, McArdle HJ, Naska A, Nowicka G, Pentieva K, Sanz Y, Siani A, Sjodin A, Stern M, Tome D, Van Loveren H, Vinceti M, Willatts P, Lamberg-Allardt C, Przyrembel H, Tetens I, Dumas C, Fabiani L, Ioannidou S, Neuhauser-Berthold M. Dietary reference values for vitamin K. EFSA J. 2017 May 22;15(5):e04780. doi: 10.2903/j.efsa.2017.4780. eCollection 2017 May.
- Background: PubMed 22517389Goodman GP, Schoenfeld AJ, Owens BD, Dutton JR, Burks R, Belmont PJ. Non-emergent orthopaedic injuries sustained by soldiers in Operation Iraqi Freedom. J Bone Joint Surg Am. 2012 Apr 18;94(8):728-35. doi: 10.2106/JBJS.K.00129.
- Background: PubMed 25027064Hughes JM, Smith MA, Henning PC, Scofield DE, Spiering BA, Staab JS, Hydren JR, Nindl BC, Matheny RW Jr. Bone formation is suppressed with multi-stressor military training. Eur J Appl Physiol. 2014 Nov;114(11):2251-9. doi: 10.1007/s00421-014-2950-6. Epub 2014 Jul 16.
- Background: PubMed 17344510Hypponen E, Power C. Hypovitaminosis D in British adults at age 45 y: nationwide cohort study of dietary and lifestyle predictors. Am J Clin Nutr. 2007 Mar;85(3):860-8. doi: 10.1093/ajcn/85.3.860.
- Background: PubMed 24109098Inklebarger J, Griffin M, Taylor MJ, Dembry RB. Femoral and tibial stress fractures associated with vitamin D insufficiency. J R Army Med Corps. 2014 Mar;160(1):61-3. doi: 10.1136/jramc-2013-000085. Epub 2013 Jun 26.
- Background: PubMed 24706237Knapik JJ, East WB. History of United States Army physical fitness and physical readiness training. US Army Med Dep J. 2014 Apr-Jun:5-19.
- Background: PubMed 19152676Kull M Jr, Kallikorm R, Tamm A, Lember M. Seasonal variance of 25-(OH) vitamin D in the general population of Estonia, a Northern European country. BMC Public Health. 2009 Jan 19;9:22. doi: 10.1186/1471-2458-9-22.
- Background: PubMed 16482069Laaksi IT, Ruohola JP, Ylikomi TJ, Auvinen A, Haataja RI, Pihlajamaki HK, Tuohimaa PJ. Vitamin D fortification as public health policy: significant improvement in vitamin D status in young Finnish men. Eur J Clin Nutr. 2006 Aug;60(8):1035-8. doi: 10.1038/sj.ejcn.1602414. Epub 2006 Feb 15.
- Background: PubMed 17823437Laaksi I, Ruohola JP, Tuohimaa P, Auvinen A, Haataja R, Pihlajamaki H, Ylikomi T. An association of serum vitamin D concentrations < 40 nmol/L with acute respiratory tract infection in young Finnish men. Am J Clin Nutr. 2007 Sep;86(3):714-7. doi: 10.1093/ajcn/86.3.714.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Madis Rahu, PhD study director
University of Tartu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D3 capsules 4000IU/100µg. and Vitamin D3 capsules 600IU/15µg. in people with Vitamin D Deficiency and Military Activity, run by Tartu University Hospital at 1 site in Estonia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Estonia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of vitamin D between study groups (Baseline, no intervention) (time frame: 0 months Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04939636, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2022.