Vitamin D DeficiencyNCT02662491
Effects of Vitamin D and Calcium Supplementation on Health and Well-being of Vitamin D Deficient UAE Citizens
A study testing Vitamin D and calcium, Vitamin D and Calcium in people with Vitamin D Deficiency, run by United Arab Emirates University at 1 site in United Arab Emirates.
Trial summary
The trial plan to determine whether a daily capsule containing vitamin D(3) (2000 IU), calcium (600 mg), both, or a placebo for 6 months in UAE citizens with evidence of vitamin D deficiency will lead to a clinical benefit. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- Vitamin D and calcium, Vitamin D and Calcium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 545 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- Jan 2017to 15 Mar 2019
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. biochemical evidence of vitamin D deficiency
Who cannot join
- renal disease or stones or hypercalcaemia,
- Use of calcium and/or vitamin D supplementation, bisphosphonates, steroid medications, hormones or diuretics.
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site
College of Medicine & Health Science
Al Ain City, Abu Dhabi Emirate
About this study
Official title: Effects of Vitamin D and Calcium Supplementation on Health of UAE Citizens
The trial plan to determine whether a daily capsule containing vitamin D(3) (2000 IU), calcium (600 mg), both, or a placebo for 6 months in UAE citizens with evidence of vitamin D deficiency will lead to a clinical benefit. The proposed study will also determine the threshold of vitamin D and calcium intake or levels considered optimal for UAE citizen's health
Read the detailed description
The proposed study is a two by two factorial, randomized controlled intervention trial. Following informed written consent of eligible subject's blood and urine samples will be taken for measurements of vitamin D, markers of bone turnover and related biochemical variables. Patients who have evidence of vitamin D deficiency will then be randomly assigned to receive daily vitamin D(3) (2000 IU), calcium (1000 mg), both, or a placebo for 6 months. All subjects will have a calcium and vitamin D rich food and other lifestyle modification advises during the study period. Patients will otherwise be managed according to standard practice. Clinical assessment that includes general and self-rated health, bone density, muscle strength, physical activity and dietary intakes will be performed at baseline, and repeated at 3, 6 and 12 months post-randomisation.
Information on other important variables likely to influence vitamin D status including age, reproductive \& menopausal history, smoking, medications, adiposity, exposure to sunlight, dietary intake including supplements, skin pigmentation, chronic illness and medications will be collected and adjusted for during the analysis
- Conditions
- Vitamin D Deficiency
- Being tested
- Vitamin D and calcium, Vitamin D, Calcium, Placebo
- 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 D and calciumDietary supplement
Vitamin DDietary supplement
CalciumDietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| vitamin D and calcium | Experimental | daily oral vitamin D(3) (2000 IU) and calcium (600 mg) for 6 months Receives: Dietary Supplement: Vitamin D and calcium |
| Calcium supplement | Experimental | daily oral calcium (600 mg) for 6 months Receives: Dietary Supplement: Calcium |
| vitamin D supplement | Experimental | daily oral vitamin D(3) (2000 IU) for 6 months Receives: Dietary Supplement: Vitamin D |
| Placebo | Placebo comparator | daily placebo tablet for 6 months Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle pains
Muscle pains measured using a questionnaire
Measured: 6 months
Muscle strength
Muscle strength measured using dynamometer
Measured: 6 months
Vitamin D level
vitamin D level measured using liquid chromatography
Measured: 6 months
Secondary outcomes (2)
Dietary vitamin D intake
dietary vitamin D intake assessed by a food frequency questionnaire
Measured: 6 months
Dietary calcium intake
Dietary calcium intake assessed by a food frequency questionnaire
Measured: 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 Jan 2016 (estimated)
- Study startJan 2017
- Primary completionMar 2019
- Study completion15 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Calcium 600mg, vitamin D 2000IU, both or placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 545 participants (actual)
Sponsor and investigators
- Lead sponsor
- United Arab Emirates University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salah Gariballa, United Arab Emirates University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02662491
- Sponsor's protocol ID
- 14/05
- Other IDs
- VITD
- Status last verified
- May 2019
- First submitted
- 13 Jan 2016
- Last updated
- 9 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Gariballa S, Yasin J, Alessa A. A randomized, double-blind, placebo-controlled trial of vitamin D supplementation with or without calcium in community-dwelling vitamin D deficient subjects. BMC Musculoskelet Disord. 2022 May 3;23(1):415. doi: 10.1186/s12891-022-05364-z.
PubMed 35505326
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vitamin D and Calcium Supplementation on Health of UAE Citizens
- ClinicalTrials.gov ID
- NCT02662491
- Acronym / sponsor ID
- 14/05
- Conditions
- Vitamin D Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 545 participants (actual)
- Lead sponsor
- United Arab Emirates UniversityUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Mar 2019 (actual)
- Study completion
- 15 Mar 2019 (actual)
- First posted
- 25 Jan 2016 (estimated)
- 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 trial plan to determine whether a daily capsule containing vitamin D(3) (2000 IU), calcium (600 mg), both, or a placebo for 6 months in UAE citizens with evidence of vitamin D deficiency will lead to a clinical benefit. The proposed study will also determine the threshold of vitamin D and calcium intake or levels considered optimal for UAE citizen's health
Detailed description
The proposed study is a two by two factorial, randomized controlled intervention trial. Following informed written consent of eligible subject's blood and urine samples will be taken for measurements of vitamin D, markers of bone turnover and related biochemical variables. Patients who have evidence of vitamin D deficiency will then be randomly assigned to receive daily vitamin D(3) (2000 IU), calcium (1000 mg), both, or a placebo for 6 months. All subjects will have a calcium and vitamin D rich food and other lifestyle modification advises during the study period. Patients will otherwise be managed according to standard practice. Clinical assessment that includes general and self-rated health, bone density, muscle strength, physical activity and dietary intakes will be performed at baseline, and repeated at 3, 6 and 12 months post-randomisation.
Information on other important variables likely to influence vitamin D status including age, reproductive \& menopausal history, smoking, medications, adiposity, exposure to sunlight, dietary intake including supplements, skin pigmentation, chronic illness and medications will be collected and adjusted for during the analysis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Calcium 600mg, vitamin D 2000IU, both or placebo
| Arm | Type | Receives |
|---|---|---|
| vitamin D and calcium | Experimental | Dietary Supplement: Vitamin D and calciumdaily oral vitamin D(3) (2000 IU) and calcium (600 mg) for 6 months |
| Calcium supplement | Experimental | Dietary Supplement: Calciumdaily oral calcium (600 mg) for 6 months |
| vitamin D supplement | Experimental | Dietary Supplement: Vitamin Ddaily oral vitamin D(3) (2000 IU) for 6 months |
| Placebo | Placebo comparator | Dietary Supplement: Placebodaily placebo tablet for 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. biochemical evidence of vitamin D deficiency
Key exclusion criteria (2 listed)
- renal disease or stones or hypercalcaemia,
- Use of calcium and/or vitamin D supplementation, bisphosphonates, steroid medications, hormones or diuretics.
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 D and calcium | Dietary supplement | vitamin D and calcium |
| Vitamin D | Dietary supplement | vitamin D supplement |
| Calcium | Dietary supplement | Calcium supplement |
| Placebo | Dietary supplement | Placebo |
Primary outcome
Muscle pains
Time frame: 6 months
Muscle pains measured using a questionnaire
Muscle strength
Time frame: 6 months
Muscle strength measured using dynamometer
Vitamin D level
Time frame: 6 months
vitamin D level measured using liquid chromatography
2 secondary outcomes
Dietary vitamin D intake
Time frame: 6 months
Dietary calcium intake
Time frame: 6 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 9 May 2019.
- Derived from this study: PubMed 35505326Gariballa S, Yasin J, Alessa A. A randomized, double-blind, placebo-controlled trial of vitamin D supplementation with or without calcium in community-dwelling vitamin D deficient subjects. BMC Musculoskelet Disord. 2022 May 3;23(1):415. doi: 10.1186/s12891-022-05364-z.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 and calcium, Vitamin D and Calcium in people with Vitamin D Deficiency, run by United Arab Emirates University at 1 site in United Arab Emirates.
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 1 inclusion and 2 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 9 May 2019. 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 United Arab Emirates. 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?
Muscle pains (time frame: 6 months). The study lists 3 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 NCT02662491, which also lists 1 linked publication.
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 9 May 2019.