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

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

Study Overview

• Status: Completed
• Conditions: Vitamin D Deficiency
• Intervention / Treatment: Dietary supplement: Vitamin D; Dietary supplement: Placebo; Dietary supplement: Vitamin D and calcium; Dietary supplement: Calcium

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 Type: Interventional
• Enrollment (Actual): 545
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Arab Emirates
  • Abu Dhabi
    • Al Ain, Abu Dhabi, United Arab Emirates
      • College of Medicine & Health Science

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: vitamin D and calcium; daily oral vitamin D(3) (2000 IU) and calcium (600 mg) for 6 months	Dietary supplement: Vitamin D and calcium
Experimental: Calcium supplement; daily oral calcium (600 mg) for 6 months	Dietary supplement: Calcium
Experimental: vitamin D supplement; daily oral vitamin D(3) (2000 IU) for 6 months	Dietary supplement: Vitamin D
Placebo Comparator: Placebo; daily placebo tablet for 6 months	Dietary supplement: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle pains	Muscle pains measured using a questionnaire	6 months
Muscle strength	Muscle strength measured using dynamometer	6 months
Vitamin D level	vitamin D level measured using liquid chromatography	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dietary vitamin D intake	dietary vitamin D intake assessed by a food frequency questionnaire	6 months
Dietary calcium intake	Dietary calcium intake assessed by a food frequency questionnaire	6 months

Collaborators and Investigators

• Sponsor: United Arab Emirates University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): March 1, 2019
• Study Completion (Actual): March 15, 2019

Study Registration Dates

• First Submitted: January 13, 2016
• First Submitted That Met QC Criteria: January 22, 2016
• First Posted (Estimate): January 25, 2016

Study Record Updates

• Last Update Posted (Actual): May 9, 2019
• Last Update Submitted That Met QC Criteria: May 8, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin D Deficiency; Physiological Effects of Drugs; Micronutrients; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol; Calcium; Vitamins; Calcium, Dietary; Ergocalciferols
• Other Study ID Numbers: 14/05; VITD (UAEU)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No