Effects of Vitamin D and Calcium Supplementation on Health and Well-being of Vitamin D Deficient UAE Citizens
Primary Purpose
Vitamin D Deficiency
Status
Completed
Phase
Not Applicable
Locations
United Arab Emirates
Study Type
Interventional
Intervention
Vitamin D and calcium
Vitamin D
Calcium
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Vitamin D Deficiency
Eligibility Criteria
Inclusion Criteria:
1. 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.
Sites / Locations
- College of Medicine & Health Science
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
vitamin D and calcium
Calcium supplement
vitamin D supplement
Placebo
Arm Description
daily oral vitamin D(3) (2000 IU) and calcium (600 mg) for 6 months
daily oral calcium (600 mg) for 6 months
daily oral vitamin D(3) (2000 IU) for 6 months
daily placebo tablet for 6 months
Outcomes
Primary Outcome Measures
Muscle pains
Muscle pains measured using a questionnaire
Muscle strength
Muscle strength measured using dynamometer
Vitamin D level
vitamin D level measured using liquid chromatography
Secondary Outcome Measures
Dietary vitamin D intake
dietary vitamin D intake assessed by a food frequency questionnaire
Dietary calcium intake
Dietary calcium intake assessed by a food frequency questionnaire
Full Information
NCT ID
NCT02662491
First Posted
January 13, 2016
Last Updated
May 8, 2019
Sponsor
United Arab Emirates University
1. Study Identification
Unique Protocol Identification Number
NCT02662491
Brief Title
Effects of Vitamin D and Calcium Supplementation on Health and Well-being of Vitamin D Deficient UAE Citizens
Official Title
Effects of Vitamin D and Calcium Supplementation on Health of UAE Citizens
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
March 2019 (Actual)
Study Completion Date
March 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
United Arab Emirates University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
Calcium 600mg, vitamin D 2000IU, both or placebo
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double blind
Allocation
Randomized
Enrollment
545 (Actual)
8. Arms, Groups, and Interventions
Arm Title
vitamin D and calcium
Arm Type
Experimental
Arm Description
daily oral vitamin D(3) (2000 IU) and calcium (600 mg) for 6 months
Arm Title
Calcium supplement
Arm Type
Experimental
Arm Description
daily oral calcium (600 mg) for 6 months
Arm Title
vitamin D supplement
Arm Type
Experimental
Arm Description
daily oral vitamin D(3) (2000 IU) for 6 months
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
daily placebo tablet for 6 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D and calcium
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D
Intervention Type
Dietary Supplement
Intervention Name(s)
Calcium
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Muscle pains
Description
Muscle pains measured using a questionnaire
Time Frame
6 months
Title
Muscle strength
Description
Muscle strength measured using dynamometer
Time Frame
6 months
Title
Vitamin D level
Description
vitamin D level measured using liquid chromatography
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Dietary vitamin D intake
Description
dietary vitamin D intake assessed by a food frequency questionnaire
Time Frame
6 months
Title
Dietary calcium intake
Description
Dietary calcium intake assessed by a food frequency questionnaire
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
1. 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.
Facility Information:
Facility Name
College of Medicine & Health Science
City
Al Ain
State/Province
Abu Dhabi
Country
United Arab Emirates
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35505326
Citation
Gariballa S, Yasin J, Alessa A. A randomized, double-blind, placebo-controlled trial of vitamin D supplementation with or without calcium in community-dwelling vitamin D deficient subjects. BMC Musculoskelet Disord. 2022 May 3;23(1):415. doi: 10.1186/s12891-022-05364-z.
Results Reference
derived
Learn more about this trial
Effects of Vitamin D and Calcium Supplementation on Health and Well-being of Vitamin D Deficient UAE Citizens
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