NCT00992797

Diabetes Intervention Trial With Vitamin D in Subjects of Nordic and Sub-Indian Ethnicity

A Randomized Controlled Trial of the Effect of Vitamin D Supplementation on Insulin Sensitivity and Secretion in Subjects With Type 2 Diabetes of Nordic and Sub-Indian Ethnicity .

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University Hospital, Aker · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this 6 months study is to evaluate the metabolic effects of 400.000-600.000 IU of vitamin D supplementation in subjects with type 2 diabetes and hypovitaminosis D. The main hypothesis is that subjects with low levels of 25-OH-vitamin D will benefit from supplementation with cholecalciferol in sufficient doses to optimize serum levels.

Detailed description

Accumulating evidence suggests that hypovitaminosis D may be associated with the development of type 2 diabetes and disturbances in glucose and insulin metabolism. There is lack of data from randomized, controlled studies of sufficient duration and with the use of sufficient doses of vitamin D to assess the importance of vitamin D supplementation in glucose metabolism in type 2 diabetes.

Conditions

• Diabetes Mellitus Type 2
• Hypovitaminosis D

Interventions

Type	Name	Description
DRUG	Cholecalciferol	Cholecalciferol 200.000 IU pr ampoule, 400.000 IU given at randomization day, followed by additionally 200.000 IU at week 5 if serum 25(OH)D \< 100 nmol/L. If serum 25(OH)D \> 100 placebo will be given. The cholecalciferol will be given in orange juice.
OTHER	Orange juice	Orange juice at randomization day and at week 5.

Timeline

• Start date: 2009-09-01
• Primary completion: 2010-12-01
• Completion: 2011-12-01
• First posted: 2009-10-09
• Last updated: 2009-11-03

Locations

1 site across 1 country: Norway