Metabolic Effects of Vitamin D in Patients With Type 2 Diabetes

Phase 2

Completed

• Conditions: Type 2 Diabetes; Vitamin D Insufficiency
• Interventions: Drug: Cholecalciferol

• Registration Number: NCT00812578
• Lead Sponsor: University of Aarhus

Brief Summary

The purpose of the study is to examine the effect on metabolic parameters after 12 weeks of treatment with high dose vitamin D in patients with type 2 diabetes and vitamin D insufficiency.

Detailed Description

There is increasing evidence that vitamin D affects the risk of diabetes. The role of vitamin D in type 2 diabetes is suggested by cross sectional studies, where an inverse association between vitamin D status and the development of type 2 diabetes has been found. Moreover supplementation with calcium and vitamin D may attenuate increases in glycemia and insulin resistance in healthy older adults with IFG. However further research is needed to confirm these findings and to determine possible mechanisms of the preventive effect from vitamin D against diabetes. The aim of this study is to examine the effect on metabolic parameters such as glycemic control, lipid status, inflammatory markers, insulin resistance and insulin secretion in patients with type 2 diabetes and vitamin D insufficiency before and after a 12-week period of treatment with high doses of vitamin D.

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2008-12-19
• Study First Submitted QC: 2008-12-19
• Study First Posted: 2008-12-22
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2010-07
• Last Update Submitted: 2010-07-09
• Last Update Posted: 2010-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Informed consent
• Type 2 diabetes
• Patients of Danish extraction
• Vitamin D insufficiency (1,25OHvitD < 50 nmol/l)

Exclusion Criteria

• Nephropathy (Urea > 12 mmol/l)
• S-calcium > 2,52 mmol/L
• Primary hyperparathyroidism
• Serious disease
• Malabsorption
• Sarcoidosis
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo pill	Cholecalciferol	-
Cholecalciferol	Cholecalciferol	-

Primary Outcome Measures

Name	Time	Method
Insulin secretion and insulin resistance	6 hours

Secondary Outcome Measures

Name	Time	Method
Glycemic control, lipid status, inflammatory markers, BMD	2 months

Trial Locations

Locations (1)

Medical Research Unit, Medical Department M, Aarhus University Hospital; 🇩🇰 Aarhus, Denmark