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Metabolic Effects of Vitamin D in Patients With Type 2 Diabetes (ProjectD)

This study has been completed.
Sponsor:
Collaborators:
Aarhus University Hospital
Regionshospitalet Silkeborg
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00812578
First received: December 19, 2008
Last updated: July 9, 2010
Last verified: July 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes
Vitamin D Insufficiency
 Drug: Cholecalciferol
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Metabolic Effects of Vitamin D in Patients With Type 2 Diabetes - a Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Insulin secretion and insulin resistance [ Time Frame: 6 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Glycemic control, lipid status, inflammatory markers, BMD [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: December 2008
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cholecalciferol Drug: Cholecalciferol
8 tablets equivalent to 280 micrograms for 2 weeks and 4 tablets equivalent to 140 micrograms for 10 weeks
Placebo Comparator: Placebo pill Drug: Cholecalciferol
8 tablets equivalent to 280 micrograms for 2 weeks and 4 tablets equivalent to 140 micrograms for 10 weeks

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00812578

Locations
Denmark
Medical Research Unit, Medical Department M, Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital
Regionshospitalet Silkeborg
Investigators
Principal Investigator: Lotte Oeskov, MD Medical Department, Silkeborg Hospital, Falkevej 1-3, 8600 Silkeborg, Denmark
  More Information

No publications provided

Responsible Party: MD, Med. Sci. Lotte Oerskov, Medical Department, Silkeborg Hospital
ClinicalTrials.gov Identifier: NCT00812578     History of Changes
Other Study ID Numbers: UKO-1006-2008
Study First Received: December 19, 2008
Last Updated: July 9, 2010
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency
Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
Type 2 diabetes
Vitamin D insufficiency
Insulin secretion
Insulin sensitivity
Pulsatility

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Cholecalciferol
Vitamin D
 Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on May 19, 2013