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Completed

NCT Number: NCT00812578

Metabolic Effects of Vitamin D in Patients With Type 2 Diabetes

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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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases Vitamin D Insufficiency

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Medical Research Unit, Medical Department M, Aarhus University Hospital

Aarhus, 8000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cholecalciferol

Drug

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

Primary outcomes

  1. Insulin secretion and insulin resistance

    Time frame: 6 hours

Secondary outcomes

  1. Glycemic control, lipid status, inflammatory markers, BMD

    Time frame: 2 months

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aarhus University Hospital
  • Regionshospitalet Silkeborg

Registry information

Official study title

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

Acronym: ProjectD

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Dec 22, 2008
Registry last updated
Jul 12, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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