An interventional study of Vitamin D and calcium and Vitamin D in Vitamin D Deficiency, sponsored by United Arab Emirates University. Completed at 1 site in United Arab Emirates. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-09.
Sponsored by United Arab Emirates University · Not applicable, Interventional, and Treatment
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
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
772 studies on the registry are indexed under Vitamin D Deficiency; 61 are open to participants now.
This study's enrollment of 545 is above the median of 77 across 564 interventional studies indexed under Vitamin D Deficiency.
Browse Vitamin D Deficiency studies →United Arab Emirates University is the lead sponsor of 24 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
daily oral vitamin D(3) (2000 IU) and calcium (600 mg) for 6 months
Dietary Supplement: Vitamin D and calcium
daily oral calcium (600 mg) for 6 months
Dietary Supplement: Calcium
daily oral vitamin D(3) (2000 IU) for 6 months
Dietary Supplement: Vitamin D
daily placebo tablet for 6 months
Dietary Supplement: Placebo
Muscle pains
Muscle pains measured using a questionnaire
Time frame: 6 months
Muscle strength
Muscle strength measured using dynamometer
Time frame: 6 months
Vitamin D level
vitamin D level measured using liquid chromatography
Time frame: 6 months
Dietary vitamin D intake
dietary vitamin D intake assessed by a food frequency questionnaire
Time frame: 6 months
Dietary calcium intake
Dietary calcium intake assessed by a food frequency questionnaire
Time frame: 6 months
Plan to share: No
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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United Arab Emirates University