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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02662491
Enrollment
545
Registered
2016-01-25
Start date
2017-01-31
Completion date
2019-03-15
Last updated
2019-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vitamin D Deficiency

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

Interventions

DIETARY_SUPPLEMENTVitamin D and calcium
DIETARY_SUPPLEMENTVitamin D
DIETARY_SUPPLEMENTCalcium
DIETARY_SUPPLEMENTPlacebo

Sponsors

United Arab Emirates University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Double blind

Intervention model description

Calcium 600mg, vitamin D 2000IU, both or placebo

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Muscle pains6 monthsMuscle pains measured using a questionnaire
Muscle strength6 monthsMuscle strength measured using dynamometer
Vitamin D level6 monthsvitamin D level measured using liquid chromatography

Secondary

MeasureTime frameDescription
Dietary vitamin D intake6 monthsdietary vitamin D intake assessed by a food frequency questionnaire
Dietary calcium intake6 monthsDietary calcium intake assessed by a food frequency questionnaire

Countries

United Arab Emirates

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026