NCT00685594

Vitamin D for the Prevention of Diabetes Type 2

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 511 (actual)
• Sponsor: University of Tromso · Academic / Other
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Impaired Glucose Tolerance

Interventions

Type	Name	Description
DRUG	cholecalciferol	20.000 IU cholecalciferol per week for 5 years versus placebo
DRUG	Placebo	Placebo capsule once a week, identical to cholecalciferol capsule

Timeline

• Start date: 2008-03-01
• Primary completion: 2015-03-01
• Completion: 2015-09-01
• First posted: 2008-05-28
• Last updated: 2015-09-22

Locations

1 site across 1 country: Norway