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

Diabetes Mellitus Type 2 Clinical Trial

Official title: 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 Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Avitaminosis
• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2
• Hypovitaminosis D
• Rickets
• Vitamin D Deficiency

• NCT number: NCT00992797
• Study type: Interventional
• Source: University Hospital, Aker
• Contact: Gulseth Wium, MD
• Phone: 4722894745
• Email: diabeteslab@aus.no
• Status: Recruiting
• Phase: Phase 2
• Start date: September 2009
• Completion date: December 2011