Vitamin D for the Prevention of Diabetes Type 2

Phase 2

Completed

• Conditions: Impaired Glucose Tolerance
• Interventions: Drug: cholecalciferol; Drug: Placebo

• Registration Number: NCT00685594
• Lead Sponsor: University of Tromso

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-05-09
• Study First Submitted QC: 2008-05-27
• Study First Posted: 2008-05-28
• Primary Completion: 2015-03
• Status Verified: 2015-09
• Study Completion: 2015-09
• Last Update Submitted: 2015-09-18
• Last Update Posted: 2015-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 511

Inclusion Criteria

• Impaired glucose tolerance

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	cholecalciferol	Cholecalciferol 20.000 IU per week for 5 years
2	Placebo	-

Primary Outcome Measures

Name	Time	Method
development of diabetes type 2	5 years

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Tromso; 🇳🇴 Tromso, Norway