Effects of Vitamin D and Calcium Supplementation on Health and Well-being of Vitamin D Deficient UAE Citizens

Study Overview
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Brief Summary
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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
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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

Official Title
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Effects of Vitamin D and Calcium Supplementation on Health of UAE Citizens

Conditions
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Vitamin D Deficiency

Intervention / Treatment
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* Dietary Supplement: Vitamin D and calcium
* Dietary Supplement: Vitamin D
* Dietary Supplement: Calcium
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. biochemical evidence of vitamin D deficiency Exclusion Criteria: renal disease or stones or hypercalcaemia, Use of calcium and/or vitamin D supplementation, bisphosphonates, steroid medications, hormones or diuretics.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: Calcium 600mg, vitamin D 2000IU, both or placebo
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vitamin D and calcium<br>daily oral vitamin D(3) (2000 IU) and calcium (600 mg) for 6 months | Dietary Supplement: Vitamin D and calcium<br> <br> |
| Experimental: Calcium supplement<br>daily oral calcium (600 mg) for 6 months | Dietary Supplement: Calcium<br> <br> |
| Experimental: vitamin D supplement<br>daily oral vitamin D(3) (2000 IU) for 6 months | Dietary Supplement: Vitamin D<br> <br> |
| Placebo Comparator: Placebo<br>daily placebo tablet for 6 months | Dietary Supplement: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle pains | Muscle pains measured using a questionnaire | 6 months | 
| Muscle strength | Muscle strength measured using dynamometer | 6 months | 
| Vitamin D level | vitamin D level measured using liquid chromatography | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dietary vitamin D intake | dietary vitamin D intake assessed by a food frequency questionnaire | 6 months | 
| Dietary calcium intake | Dietary calcium intake assessed by a food frequency questionnaire | 6 months |