Effect of Vitamin D Supplementation on the Metabolic Control and Body Composition of Type 2 Diabetes Subjects in Ajman (UAE) (VDIS)

March 29, 2014 updated by: Dr.Amena Sadiya, Rashid Centre for Diabetes and Research
The incidence of type 2 diabetes mellitus and obesity is increasing at an alarming rate both nationally and worldwide. Accumulating evidence suggests that serum cholecalciferol levels may be inversely related to the prevalence of diabetes, insulin resistance and metabolic syndrome. However, to demonstrate a causal relation between vitamin D and glucose metabolism, evidence from randomized and adequately powered placebo-controlled intervention trials is needed.The trials available on the effect of Vitamin D supplementation are not conclusive. Hence, the purpose of this study was to conduct a double-blind randomized trial in Vitamin D deficient obese type 2 diabetic Emirati population to clarify the effect of vitamin D supplementation on glycemic control and obesity parameters.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Vitamin D insufficiency has been reported as a risk factor for the development of type 1 and type 2 diabetes mellitus. In contrast to the findings of the observational studies, the supplementation trials in type 2 diabetes mellitus (T2DM) do not report any definitive conclusions, but it does suggest that supplementation at an early stage in the development of diabetes may be of benefit in delaying progression to clinical T2DM by increasing the pancreatic insulin release and improved insulin resistance plus impaired glucose tolerance.There is also speculation on role of vitamin D in physiology of weight loss and body composition.However, there have been multiple inconsistencies within the reported trial i.e. sample size, dose of vitamin D, frequency of supplementation, and population studied.

Hence the randomised clinical trial was undertaken to study the effect of vitamin D (Cholecalciferol) supplementation on metabolic markers and obesity parameters in the vitamin D deficient obese type 2 diabetic subjects.

Study Type

Interventional

Enrollment (Actual)

87

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • United Arab Emirates national
  • Male or Female
  • Age 30-65 years
  • Diagnosed as type 2 diabetes
  • Body Mass Index ≥30 kg/m2
  • Serum 25 hydroxy Vitamin D ≤ 50nmol/L

Exclusion Criteria:

  • Type 1 diabetes mellitus
  • History or evidence of liver failure (elevated liver function tests) or renal failure ( elevated creatinine)
  • History of malabsorption syndrome.
  • On vitamin D Supplementation
  • On hormone replacement therapy
  • On corticosteroids, anticonvulsants, AIDS medication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vitamin D3 group
supplemented with 6000IU cholecalciferol/day for 3 months, followed by 3000 IU cholecalciferol/day for next 3 months
Dietary supplement: Vitamin D3(cholecalciferol)
Other Names:
  • cholecalciferol
Placebo Comparator: Placebo group
Placebo (starch) capsules identical to vitamin D capsules in appearance
Dietary supplement: Vitamin D3(cholecalciferol)
Other Names:
  • cholecalciferol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
glycemic control
Time Frame: 6 months
HbA1c, Fasting Blood glucose, C-peptide
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lipid Profile
Time Frame: 6 months
Serum Total cholesterol, LDL-C, HDL-C, Triglyceride, Apolipoprotein A and B
6 months
Vitamin D
Time Frame: 6 months
Serum 25-hydroxyvitamin D, Parathyroid hormone, Calcium, Phosphate, Alkaline phosphatase
6 months
Other metabolic markers
Time Frame: 6 months
High sensitive C-Reactive Protein, Creatinine, Thyroid stimulating hormone, Systolic Blood pressure, Diastolic Blood pressure
6 months
Obesity Parameter
Time Frame: 6 monhts
Weight, BMI, waist circumference, Fat mass, Muscle mass, water mass
6 monhts

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rashid Centre for Diabetes and Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

March 26, 2014

First Submitted That Met QC Criteria

March 29, 2014

First Posted (Estimate)

April 2, 2014

Study Record Updates

Last Update Posted (Estimate)

April 2, 2014

Last Update Submitted That Met QC Criteria

March 29, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VDIS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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