College of Medicine & Health Science
Al Ain City, Abu Dhabi Emirate, United Arab Emirates
NCT Number: NCT02662491
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
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Al Ain City, Abu Dhabi Emirate, United Arab Emirates
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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 6 months
Muscle pains measured using a questionnaire
Time frame: 6 months
Muscle strength measured using dynamometer
Time frame: 6 months
vitamin D level measured using liquid chromatography
Time frame: 6 months
dietary vitamin D intake assessed by a food frequency questionnaire
Time frame: 6 months
Dietary calcium intake assessed by a food frequency questionnaire
United Arab Emirates University
Other
Effects of Vitamin D and Calcium Supplementation on Health of UAE Citizens
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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