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

United Arab Emirates University

Status: Completed

Conditions: Vitamin D Deficiency

Treatments: Dietary Supplement: Calcium; Dietary Supplement: Placebo; Dietary Supplement: Vitamin D; Dietary Supplement: Vitamin D and calcium

Study type: Interventional

Funder types: Other

Identifiers

NCT02662491

14/05

VITD (Other Identifier)

Details and patient eligibility

About

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

Full 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

Enrollment: 545 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. biochemical evidence of vitamin D deficiency

Exclusion criteria

1. renal disease or stones or hypercalcaemia,
2. Use of calcium and/or vitamin D supplementation, bisphosphonates, steroid medications, hormones or diuretics.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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545 participants in 4 patient groups, including a placebo group

vitamin D and calcium

Experimental group

Description:

daily oral vitamin D(3) (2000 IU) and calcium (600 mg) for 6 months

Treatment:

Dietary Supplement: Vitamin D and calcium

Calcium supplement

Experimental group

Description:

daily oral calcium (600 mg) for 6 months

Treatment:

Dietary Supplement: Calcium

vitamin D supplement

Experimental group

Description:

daily oral vitamin D(3) (2000 IU) for 6 months

Treatment:

Dietary Supplement: Vitamin D

Placebo

Placebo Comparator group

Description:

daily placebo tablet for 6 months

Treatment:

Dietary Supplement: Placebo