Chronic Low-back PainNCT06082375
Supplementation With Vitamin D3 on Chronic Low Back Pain Patient
A study testing Vitamin D in people with Chronic Low-back Pain, run by Medical University of Gdansk at 1 site in Poland.
Trial summary
The study was designed as a randomized double-blind placebo-controlled clinical trial with 8-week Vitamin D3 and physical activity intervention. The protocol was approved by Independent Bioethics Committee for Scientific Research at Medical University of Gdańsk (No. Read more about this study
- Who is it for?
- Ages 30 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- Vitamin D
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 sitePoland
- Study dates
- 1 Aug 2019to 1 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 30 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pain in the lumbar spine that lasts more than 6 months (diagnosed by signs and symptoms, and tests such as magnetic resonance imaging (MRI));
- Failure to respond to medications and physical therapies;
- Visual Analog Pain Scale (VAS), (0-100) score greater than or equal to 50;
- Numerical Rating Scale (NRS);
Who cannot join
- Rheumatoid arthritis;
- Diagnosed mental illness;
- Drugs;
- Metabolic bone diseases (hypo or hyperparasitism);
- Chronic kidney diseases and diseases affecting vitamin D metabolism (stomach surgery, chronic liver diseases, kidney failure, malabsorption disorders, systemic infection, tumors, etc.)
- Medicines that alter the metabolism of bones such as corticosteroids or bisphosphonates;
- Vitamin D supplements in the last 3 months;
- BMI: less than 19;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of 8-week Supplementation With Vitamin D3 on Functional and Cognitive Performance in Patients With Chronic Low Back Pain Eligible for Neurosurgery Intervention
The study was designed as a randomized double-blind placebo-controlled clinical trial with 8-week Vitamin D3 and physical activity intervention. The protocol was approved by Independent Bioethics Committee for Scientific Research at Medical University of Gdańsk (No. 525/2018), in accordance with the Declaration of Helsinki. We enrol 40 patient (aged ≥ 35), Patients diagnosed with chronic pain in the lumbar spine, qualified for surgical treatment at the Department of Neurosurgery Medicinal Unit in Gdańsk. Participation in the study was voluntary, and the condition for participation was obtaining informed consent from the patient.
Read the detailed description
Before starting supplementation, a blood sample was taken from patients to determine the status of vitamin D3, measurements of hydroxylated vitamin D at position 25 (25OHD3) and monitoring of inflammatory markers such as Interleukin-6; TumorNecrosisFactor-α. This measurement was performed in the University laboratory in Gdańsk according to a standard, generally accepted method for the determination of a given compound. The blood sample was taken by a qualified nurse. This measurement was repeated to control vitamin D levels and markers of inflammation:
- After 6 weeks of supplementation (before surgery);
- After 2 weeks of supplementation (after surgery);
Patients was supplemented with vitamin D or placebo for 6 weeks before surgery and was continue supplementation for 6 weeks after surgery. According to the value of the Body Mass Index, the dose of vitamin D will be appropriately selected for each group:
- Group 1 BMI 19-25 - 4000 IU
- Group 2 BMI 25-29,9- 6000 IU
- Group 3 BMI >30- 8000 IU
A person was appointed to coordinate the allocation of patients to the two groups. Patients was not informed whether they are receiving vitamin D or a placebo. The treating doctors, radiology specialists and the rest of the team was not know what group the patient is in. Within individual groups, patients was randomly assigned to:
- Group A - patients supplemented with placebo;
- Group B - patients supplemented with vitamin D3; Patients was informed about the purpose of the research and was receive. The patients diet was monitored during supplementation by a certified clinical dietitian using food diaries. The food diary is a basic tool for monitoring the diet of test subjects. After appropriate training, the respondents are able to fill in the diary on their own, writing down all the meals eaten during the day and snacks with drinks. It is a qualitative and quantitative method that allows you to analyze the diet so far and draw appropriate conclusions.
Patients from both groups who will not have contraindications to exercise, 2 weeks after surgery, was divided into a group for 6 weeks of home routine physical activity and a group not doing any additional physical activity.
- Group A1 - placebo supplementation + exercise
- Group A2 - placebo supplementation + no exercise
- Group B1 - supplementation with vit. D + exercises
- Group B2 - supplementation with vit. D + no exercise
- Conditions
- Chronic Low-back Pain
- Being tested
- Vitamin D, Placebo
- Keywords
- chronic low back pain, vitamin D, neurosurgery, functional, cognitive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDietary supplement
Also called cholecalciferol
Vitamin D3 in the form of cholecalciferol.
PlaceboDietary supplement
Vegetable oil.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D | Experimental | Individually adapted to each participant based on BMI, dose of vitamin D3 in drops.
1. BMI 19-25 - 4000 IU
2. BMI 25-29,9- 6000 IU
3. BMI >30- 8000 IU Receives: Dietary Supplement: Vitamin D |
| Placebo | Placebo comparator | The placebo group will receive drops containing vegetable oil in the same bottles as vitamin D3. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in vitamin D3 status at blood serum
Blood sample will be taken from patients to determine the status of vitamin D3, measurements of hydroxylated vitamin D at position 25 (25OHD3)
Measured: Baseline and Week 8
Change in vitamin Interleukin-6 status at blood serum
Blood sample will be taken from patients to determine the status of interleukin-6, measurements to show changes in inflammation in the blood.
Measured: Baseline and Week 8
Change in vitamin TumorNecrosisFactor-alfa status at blood serum
Blood sample will be taken from patients to determine the status of Tumor Necrosis Factor, measurements to show changes in inflammation in the blood.
Measured: Baseline and Week 8
Change in cognitive test Quality of life Short Form-36 questionnaire
Validated cognitive tests assessing patients' quality of life. The Short Form - 36 consists of eight scaled scores, which are the weighted sums of the questions in their section. 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. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
The eight sections are:
- vitality
- physical functioning
- bodily pain
- general health perceptions
- physical role functioning
- emotional role functioning
- social role functioning
- mental health or emotional wellbeing
Measured: Baseline and Week 8
Change in cognitive test Chalder Fatigue Questionnaire
Validated cognitive tests assessing patients' quality of life.
The subject answers the questions using a 4-step scale (choosing between "better than usual," "no more than usual," "worse than usual" and "much worse than usual"). Answers to the first 7 items give an insight into the intensity of the physical fatigue and the next 4 give a picture of the mental fatigue. The overall score is obtained by adding all the items. There are 2 scoring systems:
- a Likert system, where the subject's answers are evaluated by awarding 0, 1, 2 or 3 pts, giving a maximum of 33 pts;
- a bimodal system, which ignores the severity of responses and categorizes the answers as a "problem" ("more than usual" and "much more than usual" - 1 pt) or "no problem" ("less than usual" and "no more than usual" - 0 pt), giving a maximum of 11 pts.
Measured: Baseline and Week 8
Change in functional test Up&Go
Up\&Go Test aimed at checking the task completion time as a functional element. Patients wear their regular footwear and can use a walking aid, if needed. Begin by having the patient sit back in a standard arm chair and identify a line 3 meters, or 10 feet away, on the floor.
For password: "Go," the patient begins:
- Stand up from the chair. 2. Walk to the line on the floor at your normal pace.
- Turn. 4. Walk back to the chair at your normal pace. 5. Sit down again. On the word "Go," begin timing. Stop timing after patient sits back down. Record time: time in Seconds.
Measured: Baseline and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start1 Aug 2019
- Primary completion1 May 2021
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
- More trials run by Medical University of GdanskThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patryk Chromiec, Medical University of Gdansk
- Investigators
- Jan Kaczor, Professor, Study chair, Medical University of Gdansk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06082375
- Sponsor's protocol ID
- SVITD
- Status last verified
- Oct 2023
- First submitted
- 27 Sep 2023
- Last updated
- 13 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of 8-week Supplementation With Vitamin D3 on Functional and Cognitive Performance in Patients With Chronic Low Back Pain Eligible for Neurosurgery Intervention
- ClinicalTrials.gov ID
- NCT06082375
- Acronym / sponsor ID
- SVITD
- Conditions
- Chronic Low-back Pain
- Keywords
- chronic low back pain, vitamin D, neurosurgery, functional, cognitive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 13 Oct 2023 (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.
The study was designed as a randomized double-blind placebo-controlled clinical trial with 8-week Vitamin D3 and physical activity intervention. The protocol was approved by Independent Bioethics Committee for Scientific Research at Medical University of Gdańsk (No. 525/2018), in accordance with the Declaration of Helsinki. We enrol 40 patient (aged ≥ 35), Patients diagnosed with chronic pain in the lumbar spine, qualified for surgical treatment at the Department of Neurosurgery Medicinal Unit in Gdańsk. Participation in the study was voluntary, and the condition for participation was obtaining informed consent from the patient.
Detailed description
Before starting supplementation, a blood sample was taken from patients to determine the status of vitamin D3, measurements of hydroxylated vitamin D at position 25 (25OHD3) and monitoring of inflammatory markers such as Interleukin-6; TumorNecrosisFactor-α. This measurement was performed in the University laboratory in Gdańsk according to a standard, generally accepted method for the determination of a given compound. The blood sample was taken by a qualified nurse. This measurement was repeated to control vitamin D levels and markers of inflammation:
- After 6 weeks of supplementation (before surgery);
- After 2 weeks of supplementation (after surgery);
Patients was supplemented with vitamin D or placebo for 6 weeks before surgery and was continue supplementation for 6 weeks after surgery. According to the value of the Body Mass Index, the dose of vitamin D will be appropriately selected for each group:
- Group 1 BMI 19-25 - 4000 IU
- Group 2 BMI 25-29,9- 6000 IU
- Group 3 BMI >30- 8000 IU
A person was appointed to coordinate the allocation of patients to the two groups. Patients was not informed whether they are receiving vitamin D or a placebo. The treating doctors, radiology specialists and the rest of the team was not know what group the patient is in. Within individual groups, patients was randomly assigned to:
- Group A - patients supplemented with placebo;
- Group B - patients supplemented with vitamin D3; Patients was informed about the purpose of the research and was receive. The patients diet was monitored during supplementation by a certified clinical dietitian using food diaries. The food diary is a basic tool for monitoring the diet of test subjects. After appropriate training, the respondents are able to fill in the diary on their own, writing down all the meals eaten during the day and snacks with drinks. It is a qualitative and quantitative method that allows you to analyze the diet so far and draw appropriate conclusions.
Patients from both groups who will not have contraindications to exercise, 2 weeks after surgery, was divided into a group for 6 weeks of home routine physical activity and a group not doing any additional physical activity.
- Group A1 - placebo supplementation + exercise
- Group A2 - placebo supplementation + no exercise
- Group B1 - supplementation with vit. D + exercises
- Group B2 - supplementation with vit. D + no exercise
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D | Experimental | Dietary Supplement: Vitamin DIndividually adapted to each participant based on BMI, dose of vitamin D3 in drops. 1. BMI 19-25 - 4000 IU 2. BMI 25-29,9- 6000 IU 3. BMI >30- 8000 IU |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboThe placebo group will receive drops containing vegetable oil in the same bottles as vitamin D3. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Pain in the lumbar spine that lasts more than 6 months (diagnosed by signs and symptoms, and tests such as magnetic resonance imaging (MRI));
- Failure to respond to medications and physical therapies;
- Visual Analog Pain Scale (VAS), (0-100) score greater than or equal to 50;
- Numerical Rating Scale (NRS);
Key exclusion criteria (8 listed)
- Rheumatoid arthritis;
- Diagnosed mental illness;
- Drugs;
- Metabolic bone diseases (hypo or hyperparasitism);
- Chronic kidney diseases and diseases affecting vitamin D metabolism (stomach surgery, chronic liver diseases, kidney failure, malabsorption disorders, systemic infection, tumors, etc.)
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 DAlso: cholecalciferolVitamin D3 in the form of cholecalciferol. | Dietary supplement | Vitamin D |
| PlaceboVegetable oil. | Dietary supplement | Placebo |
Primary outcome
Change in vitamin D3 status at blood serum
Time frame: Baseline and Week 8
Blood sample will be taken from patients to determine the status of vitamin D3, measurements of hydroxylated vitamin D at position 25 (25OHD3)
Change in vitamin Interleukin-6 status at blood serum
Time frame: Baseline and Week 8
Blood sample will be taken from patients to determine the status of interleukin-6, measurements to show changes in inflammation in the blood.
Change in vitamin TumorNecrosisFactor-alfa status at blood serum
Time frame: Baseline and Week 8
Blood sample will be taken from patients to determine the status of Tumor Necrosis Factor, measurements to show changes in inflammation in the blood.
Change in cognitive test Quality of life Short Form-36 questionnaire
Time frame: Baseline and Week 8
Validated cognitive tests assessing patients' quality of life. The Short Form - 36 consists of eight scaled scores, which are the weighted sums of the questions in their section. 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. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. The eight sections are: * vitality * physical functioning * bodily pain * general health perceptions * physical role functioning * emotional role functioning * social role functioning * mental health or emotional wellbeing
Change in cognitive test Chalder Fatigue Questionnaire
Time frame: Baseline and Week 8
Validated cognitive tests assessing patients' quality of life. The subject answers the questions using a 4-step scale (choosing between "better than usual," "no more than usual," "worse than usual" and "much worse than usual"). Answers to the first 7 items give an insight into the intensity of the physical fatigue and the next 4 give a picture of the mental fatigue. The overall score is obtained by adding all the items. There are 2 scoring systems: * a Likert system, where the subject's answers are evaluated by awarding 0, 1, 2 or 3 pts, giving a maximum of 33 pts; * a bimodal system, which ignores the severity of responses and categorizes the answers as a "problem" ("more than usual" and "much more than usual" - 1 pt) or "no problem" ("less than usual" and "no more than usual" - 0 pt), giving a maximum of 11 pts.
Change in functional test Up&Go
Time frame: Baseline and Week 8
Up\&Go Test aimed at checking the task completion time as a functional element. Patients wear their regular footwear and can use a walking aid, if needed. Begin by having the patient sit back in a standard arm chair and identify a line 3 meters, or 10 feet away, on the floor. For password: "Go," the patient begins: 1. Stand up from the chair. 2. Walk to the line on the floor at your normal pace. 3. Turn. 4. Walk back to the chair at your normal pace. 5. Sit down again. On the word "Go," begin timing. Stop timing after patient sits back down. Record time: time in Seconds.
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 13 Oct 2023.
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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.
Jan Kaczor, Professor study chair
Medical University of Gdansk
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 D in people with Chronic Low-back Pain, run by Medical University of Gdansk at 1 site in Poland.
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 4 inclusion and 8 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 13 Oct 2023. 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 Poland. 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. Some participants in this study may receive a placebo. 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?
Change in vitamin D3 status at blood serum (time frame: Baseline and Week 8). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Oct 2023.