Metabolic Effects of Vitamin D in Patients With Type 2 Diabetes

Type 2 Diabetes Clinical Trial

— ProjectD  

Official title:

Metabolic Effects of Vitamin D in Patients With Type 2 Diabetes - a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00812578
• Other study ID #: UKO-1006-2008
• Status: Completed
• Phase: Phase 2
• First received: December 19, 2008
• Last updated: July 9, 2010
• Start date: December 2008
• Est. completion date: June 2010

Study information

• Verified date: July 2010
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Danish Medicines AgencyDenmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes
• Vitamin D Insufficiency

Intervention

Drug:
• Cholecalciferol
8 tablets equivalent to 280 micrograms for 2 weeks and 4 tablets equivalent to 140 micrograms for 10 weeks

Locations

Country	Name	City	State
Denmark	Medical Research Unit, Medical Department M, Aarhus University Hospital	Aarhus

Sponsors (3)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital, Regionshospitalet Silkeborg

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin secretion and insulin resistance		6 hours	No
Secondary	Glycemic control, lipid status, inflammatory markers, BMD		2 months	No