NCT02662491

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
545

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 25, 2016

Completed
11 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2019

Completed
Last Updated

May 9, 2019

Status Verified

May 1, 2019

Enrollment Period

2.2 years

First QC Date

January 13, 2016

Last Update Submit

May 8, 2019

Conditions

Vitamin D Deficiency

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • Dietary vitamin D intake

    6 months

  • Dietary calcium intake

    6 months

Study Arms (4)

vitamin D and calcium

EXPERIMENTAL

daily oral vitamin D(3) (2000 IU) and calcium (600 mg) for 6 months

Dietary Supplement: Vitamin D and calcium

Calcium supplement

EXPERIMENTAL

daily oral calcium (600 mg) for 6 months

Dietary Supplement: Calcium

vitamin D supplement

EXPERIMENTAL

daily oral vitamin D(3) (2000 IU) for 6 months

Dietary Supplement: Vitamin D

Placebo

PLACEBO COMPARATOR

daily placebo tablet for 6 months

Dietary Supplement: Placebo

Interventions

Vitamin D and calciumDIETARY_SUPPLEMENT
vitamin D and calcium
Vitamin DDIETARY_SUPPLEMENT
vitamin D supplement
CalciumDIETARY_SUPPLEMENT
Calcium supplement
PlaceboDIETARY_SUPPLEMENT
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. biochemical evidence of vitamin D deficiency

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

College of Medicine & Health Science

Al Ain City, Abu Dhabi Emirate, United Arab Emirates

Location

Related Publications (1)

  • 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.

    PMID: 35505326DERIVED

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Vitamin DCalcium

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsMetals, Alkaline EarthElementsInorganic ChemicalsMetalsBlood Coagulation FactorsBiological Factors

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double blind
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: Calcium 600mg, vitamin D 2000IU, both or placebo
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 13, 2016

First Posted

January 25, 2016

Study Start

January 1, 2017

Primary Completion

March 1, 2019

Study Completion

March 15, 2019

Last Updated

May 9, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

AE(1)