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| ID | Type | Description | Link |
|---|---|---|---|
| VITD | Other Identifier | UAEU |
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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vitamin D and calcium | Experimental | daily oral vitamin D(3) (2000 IU) and calcium (600 mg) for 6 months |
|
| Calcium supplement | Experimental | daily oral calcium (600 mg) for 6 months |
|
| vitamin D supplement | Experimental | daily oral vitamin D(3) (2000 IU) for 6 months |
|
| Placebo | Placebo Comparator | daily placebo tablet for 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D and calcium | Dietary Supplement |
| ||
| Vitamin D |
| 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 |
| 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 |
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Inclusion Criteria:
1. biochemical evidence of vitamin D deficiency
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| College of Medicine & Health Science | Al Ain City | Abu Dhabi Emirate | United Arab Emirates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35505326 | Derived | 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. |
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| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| D002118 | Calcium |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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Calcium 600mg, vitamin D 2000IU, both or placebo
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Double blind
|
| Calcium | Dietary Supplement |
|
| Placebo | Dietary Supplement |
|
| 6 months |
| D009750 |
| Nutritional and Metabolic Diseases |
| D008673 |
| Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008670 | Metals |
| D001779 | Blood Coagulation Factors |
| D001685 | Biological Factors |