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OpenTrials
Completed

NCT Number: NCT02662491

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

College of Medicine & Health Science

Al Ain City, Abu Dhabi Emirate, United Arab Emirates

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • biochemical evidence of vitamin D deficiency

Exclusion criteria

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

Treatment and study plan

Vitamin D and calcium

Dietary Supplement

Vitamin D

Dietary Supplement

Calcium

Dietary Supplement

Placebo

Dietary Supplement

Primary outcomes

  1. Muscle pains

    Time frame: 6 months

    Muscle pains measured using a questionnaire

  2. Muscle strength

    Time frame: 6 months

    Muscle strength measured using dynamometer

  3. Vitamin D level

    Time frame: 6 months

    vitamin D level measured using liquid chromatography

Secondary outcomes

  1. Dietary vitamin D intake

    Time frame: 6 months

    dietary vitamin D intake assessed by a food frequency questionnaire

  2. Dietary calcium intake

    Time frame: 6 months

    Dietary calcium intake assessed by a food frequency questionnaire

Sponsors and collaborators

Lead sponsor

United Arab Emirates University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 25, 2016
Registry last updated
May 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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