Metabolic Effects of Vitamin D in Patients With Type 2 Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2010-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Type 2 Diabetes Vitamin D Insufficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cholecalciferol

Group Type ACTIVE_COMPARATOR

Cholecalciferol

Intervention Type DRUG

8 tablets equivalent to 280 micrograms for 2 weeks and 4 tablets equivalent to 140 micrograms for 10 weeks

Placebo pill

Group Type PLACEBO_COMPARATOR

Cholecalciferol

Intervention Type DRUG

8 tablets equivalent to 280 micrograms for 2 weeks and 4 tablets equivalent to 140 micrograms for 10 weeks

Interventions

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Cholecalciferol

8 tablets equivalent to 280 micrograms for 2 weeks and 4 tablets equivalent to 140 micrograms for 10 weeks

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No