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

Vitamin D Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02662491
• Other study ID #: 14/05
• Secondary ID: VITD
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: March 15, 2019

Study information

• Verified date: May 2019
• Source: United Arab Emirates University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 545
• Est. completion date: March 15, 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Vitamin D Deficiency

Intervention

Dietary Supplement:
• Vitamin D and calcium

• Vitamin D

• Calcium

• Placebo

Locations

Country	Name	City	State
United Arab Emirates	College of Medicine & Health Science	Al Ain	Abu Dhabi

Sponsors (1)

Lead Sponsor	Collaborator
United Arab Emirates University

Country where clinical trial is conducted

United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle pains	Muscle pains measured using a questionnaire	6 months
Primary	Muscle strength	Muscle strength measured using dynamometer	6 months
Primary	Vitamin D level	vitamin D level measured using liquid chromatography	6 months
Secondary	Dietary vitamin D intake	dietary vitamin D intake assessed by a food frequency questionnaire	6 months
Secondary	Dietary calcium intake	Dietary calcium intake assessed by a food frequency questionnaire	6 months