Vitamin D DeficiencyNCT06114381
Physical Exercise and Diet Management in Vitamin D Deficient Females
A study testing Home Based Physical Exercise, Vitamin D3 Supplements and Diet Management in people with Vitamin D Deficiency, run by Badr University at 1 site in Saudi Arabia.
Trial summary
The purpose of this study was to determine if home based physical exercises protocol and Diet management has an effect on functional performance and depression level related to vitamin D deficiency in females. Read more about this study
- Who is it for?
- Ages 19 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- Home Based Physical Exercise, Vitamin D3 Supplements and Diet Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Jan 2023to 30 Jun 2023
- 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 19 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects whose age ranged from 19-25 years.
- All participants have pre laboratory results with vitamin D deficiency less than 25 nmol/L and have been lasted for 6 months
- All participated subjects were female studying at Al-Jouf university, Al- Qurrayyat-Female Branch.
Who cannot join
- Chronic illness, liver, renal endocrine or autoimmune diseases.
- Patients who suffered from any cardiopulmonary diseases.
- History of fractures or any neuro-musculoskeletal disorders.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
College of Applied Medical Sciences, Jouf University, Kingdom of Saudi Arabia
Jazan, Al Jawf Region, 85846
About this study
Official title: Impact of Home Based Physical Exercise and Diet Management on Functional Performance and Depression Among Vitamin D Deficient Females
The purpose of this study was to determine if home based physical exercises protocol and Diet management has an effect on functional performance and depression level related to vitamin D deficiency in females.
Read the detailed description
This is a randomized controlled trial to study the effect of home based physical exercises in comparison to Diet management, sun exposure and vitamin D supplements on functional performance and depression level in females with vitamin D deficiency.
- Conditions
- Vitamin D Deficiency
- Being tested
- Home Based Physical Exercise, Vitamin D3 Supplements, Diet Management, Sun Exposure
- 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.
Home Based Physical ExerciseOther
Home Exercise protocol consists of one hour divided to 3 minutes warm up",9 minutes' full body (lower limbs, abdomen, back and upper limbs) exercise composed of (aerobic and strengthening) and 3 minutes cool down 4 times per day and 15 minutes for each session 6 days with one day recovery and, with every day follow up with each patient to ensure they did the whole sets and instructed them the ways to each exercise, The total duration was 36 sessions (6 weeks) for each patient. Daily communication with all subjects through sending mobile messages 3 times every day. The message was to remind the participants and confirmation of their response.
Vitamin D3 SupplementsDietary supplement
Vitamin D3 supplement (400mg) once daily.
Diet ManagementOther
Patients receive weekly diet program contains dietary sources of Vitamin D such as yolk eggs, tuna and milk.
Sun ExposureBehavioural
Patients regular exposure to sun once a day 30 minutes of sun exposure, between 10 a.m. and 4 p.m. daily. Exposure to the face, arms, hands, and legs without sunscreen
| Study group | Role | What they receive |
|---|---|---|
| Home Based Physical Exercise | Experimental | This group composed of 30 participants who will receive full body physical exercise 6 days per week in addition to sun exposure as well as their vitamin D supplement for 6 weeks. Receives: Other: Home Based Physical Exercise; Dietary Supplement: Vitamin D3 Supplements; Behavioral: Sun Exposure |
| Diet management group | Experimental | This group composed of 30 participants who will receive dietary management and sun exposure as well as their vitamin D supplement for 6 weeks. Receives: Dietary Supplement: Vitamin D3 Supplements; Other: Diet Management; Behavioral: Sun Exposure |
| Sun Exposure and supplements | Experimental | This group composed of 30 participants who will receive only sun exposure as well as their vitamin D supplement for 6 weeks. Receives: Dietary Supplement: Vitamin D3 Supplements; Behavioral: Sun Exposure |
| Control group | No intervention | This group composed of 30 participants who didn't receive any intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin D3 blood test
Measuring of Vitamin D3 in Blood through lab test
Measured: 6 weeks
Secondary outcomes (3)
Hamilton Depression Rating Scale (HAMD)
Depression questionnaire The HDRS (also known as the Ham-D) is the most widely used clinician-administered depression assessment scale. The original version contains 17 items (HDRS 17) pertaining to symptoms of depression experienced.
The patients were brought and explained to them the method of the questionnaire, and then they answered all 17 questions and the numbers for each patient were collected and written down.
Measured: 6 weeks
6 Minutes Walk Test
Measuring the distance patient walked in 6 minutes (6 Minute walk distance)
Measured: 6 weeks
Dyspnea Borg scale
t uses a scale from 0 to 10, where 0 represents no dyspnea and 10 represents maximal dyspnea. Scores are obtained at the end of the 6MWD test and reflect the maximum degree of dyspnea at any time during the walk.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start1 Jan 2023
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Badr University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina Atef Georgui Elias, Badr University
- Investigators
- Wael OA Abd El-Khalek, Dr., Study chair, Dept of Basic Sciences, Faculty of PT, BUC, Cairo, Egypt.Doaa Saeed, Dr., Study chair, Dept of PT for women's health, Faculty of PT, BUC, Cairo, Egypt.Mina AG Elias, Dr., Study chair, Dept of PT for Internal Medicine & Geriatrics, Faculty of PT, BUC, Cairo, Egypt.Heba A Bahey El-Deen, Prof. Dr., Principal investigator, Dept of PT & Health Rehabilitation, College of Applied Medical Sciences, Jouf University, KSA.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06114381
- Sponsor's protocol ID
- BUC-IACUC-231015-43
- Status last verified
- Oct 2023
- First submitted
- 28 Oct 2023
- Last updated
- 2 Nov 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 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Home Based Physical Exercise and Diet Management on Functional Performance and Depression Among Vitamin D Deficient Females
- ClinicalTrials.gov ID
- NCT06114381
- Acronym / sponsor ID
- BUC-IACUC-231015-43
- Conditions
- Vitamin D Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Badr UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 2 Nov 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 purpose of this study was to determine if home based physical exercises protocol and Diet management has an effect on functional performance and depression level related to vitamin D deficiency in females.
Detailed description
This is a randomized controlled trial to study the effect of home based physical exercises in comparison to Diet management, sun exposure and vitamin D supplements on functional performance and depression level in females with vitamin D deficiency.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Home Based Physical Exercise | Experimental | Other: Home Based Physical Exercise, Dietary Supplement: Vitamin D3 Supplements, Behavioral: Sun ExposureThis group composed of 30 participants who will receive full body physical exercise 6 days per week in addition to sun exposure as well as their vitamin D supplement for 6 weeks. |
| Diet management group | Experimental | Dietary Supplement: Vitamin D3 Supplements, Other: Diet Management, Behavioral: Sun ExposureThis group composed of 30 participants who will receive dietary management and sun exposure as well as their vitamin D supplement for 6 weeks. |
| Sun Exposure and supplements | Experimental | Dietary Supplement: Vitamin D3 Supplements, Behavioral: Sun ExposureThis group composed of 30 participants who will receive only sun exposure as well as their vitamin D supplement for 6 weeks. |
| Control group | No intervention | –This group composed of 30 participants who didn't receive any intervention |
Who may qualify
- Ages
- 19 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Subjects whose age ranged from 19-25 years.
- All participants have pre laboratory results with vitamin D deficiency less than 25 nmol/L and have been lasted for 6 months
- All participated subjects were female studying at Al-Jouf university, Al- Qurrayyat-Female Branch.
Key exclusion criteria (3 listed)
- Chronic illness, liver, renal endocrine or autoimmune diseases.
- Patients who suffered from any cardiopulmonary diseases.
- History of fractures or any neuro-musculoskeletal disorders.
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 |
|---|---|---|
| Home Based Physical ExerciseHome Exercise protocol consists of one hour divided to 3 minutes warm up",9 minutes' full body (lower limbs, abdomen, back and upper limbs) exercise composed of (aerobic and strengthening) and 3 minutes cool down 4 times per day and 15 minutes for each session 6 days with one day recovery and, with every day follow up with each patient to ensure they did the whole sets and instructed them the ways to each exercise, The total duration was 36 sessions (6 weeks) for each patient. Daily communication with all subjects through sending mobile messages 3 times every day. The message was to remind the participants and confirmation of their response. | Other | Home Based Physical Exercise |
| Vitamin D3 SupplementsVitamin D3 supplement (400mg) once daily. | Dietary supplement | Diet management group, Home Based Physical Exercise, Sun Exposure and supplements |
| Diet ManagementPatients receive weekly diet program contains dietary sources of Vitamin D such as yolk eggs, tuna and milk. | Other | Diet management group |
| Sun ExposurePatients regular exposure to sun once a day 30 minutes of sun exposure, between 10 a.m. and 4 p.m. daily. Exposure to the face, arms, hands, and legs without sunscreen | Behavioural | Diet management group, Home Based Physical Exercise, Sun Exposure and supplements |
Primary outcome
Vitamin D3 blood test
Time frame: 6 weeks
Measuring of Vitamin D3 in Blood through lab test
3 secondary outcomes
Hamilton Depression Rating Scale (HAMD)
Time frame: 6 weeks
6 Minutes Walk Test
Time frame: 6 weeks
Dyspnea Borg scale
Time frame: 6 weeks
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 2 Nov 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.
Wael OA Abd El-Khalek, Dr. study chair
Dept of Basic Sciences, Faculty of PT, BUC, Cairo, Egypt.
Doaa Saeed, Dr. study chair
Dept of PT for women's health, Faculty of PT, BUC, Cairo, Egypt.
Mina AG Elias, Dr. study chair
Dept of PT for Internal Medicine & Geriatrics, Faculty of PT, BUC, Cairo, Egypt.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home Based Physical Exercise, Vitamin D3 Supplements and Diet Management in people with Vitamin D Deficiency, run by Badr University at 1 site in Saudi Arabia.
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 3 inclusion and 3 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 2 Nov 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 Saudi Arabia. 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?
Vitamin D3 blood test (time frame: 6 weeks). 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 2 Nov 2023.