Vitamin D for the Prevention of Diabetes Type 2

September 18, 2015 updated by: University of Tromso

Prevention of Type 2 Diabetes With Vitamin D Supplementation in Subjects With Reduced Glucose Tolerance Detected in the Tromso Study 2007/2008

The prevalence of type 2 diabetes is increasing, which for most societies has considerable consequences not only regarding health but also economy. Type 2 diabetes develops through a "prediabetic" stage with impaired glucose tolerance. Intervention at this stage with change in lifestyle or with medication may prevent such progression. There are indications that vitamin D is of importance in glucose metabolism, and that supplementation with vitamin D may increase both insulin secretion and insulin sensitivity. Accordingly, supplementation with vitamin D may improve glucose tolerance and potentially prevent the development of type 2 diabetes in subjects at risk. However, this has so far not been demonstrated in a prospective, randomised clinical study. In the present study we will therefore include 600 subjects with impaired glucose tolerance (or impaired fasting glucose) detected in the Tromso study 2007/2008 and randomize to supplementation with vitamin D 20.000IU per week or placebo for 5 years. A glucose tolerance test will be performed each year, and development of type 2 diabetes will be the main endpoint.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

511

Phase

  • Phase 2
  • Phase 3

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

  • Norway
      • Tromso, Norway, 9037
        • University of Tromso

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

21 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Impaired glucose tolerance

Exclusion Criteria:

  • Serious heart disease
  • Renal stone disease
  • Hypercalcemia
  • Sarcoidosis

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Drug: Placebo
Placebo capsule once a week, identical to cholecalciferol capsule
Experimental: 1
Cholecalciferol 20.000 IU per week for 5 years
Drug: cholecalciferol
20.000 IU cholecalciferol per week for 5 years versus placebo
Other Names:
  • vitamin D

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
development of diabetes type 2
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
change in glucose metabolism
Time Frame: 5 years
5 years
change in lipid status
Time Frame: 5 years
5 years
change in mood
Time Frame: 5 years
5 years
change in BMD hip
Time Frame: 5 years
5 years
change in intima media thickness carotid artery
Time Frame: 5 years
5 years
change in frequency of infections
Time Frame: 5 years
5 years
change in blood pressure
Time Frame: 5 years
5 years
Change in Insulin sensitivity
Time Frame: 5 years
5 years
change in HbA1c
Time Frame: 5 years
5 years
change in weight
Time Frame: 5 years
5 years
change in telomer length
Time Frame: 5 years
5 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oral glucose tolerance response to vitamin D supplementation in relation to polymorphisms in the vitamin D system
Time Frame: 1 year
The response to oral glucose tolerance test (fasting and 2 h blood glucose, serum insulin, C-peptide, measures of insulin resistiance as well as metabolic parameters (lipids, blood pressure)) will be evaluated in the results at the 1-year visit in relation to genetic polymorphisms in the vitamin D system
1 year

Collaborators and Investigators

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

Sponsor

University of Tromso

Collaborators

University Hospital of North Norway

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

March 1, 2008

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

May 9, 2008

First Submitted That Met QC Criteria

May 27, 2008

First Posted (Estimate)

May 28, 2008

Study Record Updates

Last Update Posted (Estimate)

September 22, 2015

Last Update Submitted That Met QC Criteria

September 18, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UIT-ENDO-2008-1
  • NFR 184766/V50

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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