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

Not Applicable

Completed

• Conditions: Vitamin D Deficiency
• Interventions: Dietary Supplement: Calcium; Dietary Supplement: Placebo; Dietary Supplement: Vitamin D and calcium; Dietary Supplement: Vitamin D

• Registration Number: NCT02662491
• Lead Sponsor: United Arab Emirates University

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2016-01-13
• Study First Submitted QC: 2016-01-22
• Study First Posted: 2016-01-25
• Study Start: 2017-01
• Primary Completion: 2019-03
• Study Completion: 2019-03-15
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-08
• Last Update Posted: 2019-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 545

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Calcium supplement	Calcium	daily oral calcium (600 mg) for 6 months
Placebo	Placebo	daily placebo tablet for 6 months
vitamin D and calcium	Vitamin D and calcium	daily oral vitamin D(3) (2000 IU) and calcium (600 mg) for 6 months
vitamin D supplement	Vitamin D	daily oral vitamin D(3) (2000 IU) for 6 months

Primary Outcome Measures

Name	Time	Method
Muscle pains	6 months	Muscle pains measured using a questionnaire
Muscle strength	6 months	Muscle strength measured using dynamometer
Vitamin D level	6 months	vitamin D level measured using liquid chromatography

Secondary Outcome Measures

Name	Time	Method
Dietary calcium intake	6 months	Dietary calcium intake assessed by a food frequency questionnaire
Dietary vitamin D intake	6 months	dietary vitamin D intake assessed by a food frequency questionnaire

Trial Locations

Locations (1)

College of Medicine & Health Science; 🇦🇪 Al Ain, Abu Dhabi, United Arab Emirates