Metabolic Effects of Vitamin D in Patients With Type 2 Diabetes (ProjectD)
July 9, 2010 updated by: University of Aarhus
Metabolic Effects of Vitamin D in Patients With Type 2 Diabetes - a Randomized Controlled Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
16
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Aarhus, Denmark, 8000
- Medical Research Unit, Medical Department M, Aarhus University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Placebo pill
|
8 tablets equivalent to 280 micrograms for 2 weeks and 4 tablets equivalent to 140 micrograms for 10 weeks
|
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Active Comparator: Cholecalciferol
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8 tablets equivalent to 280 micrograms for 2 weeks and 4 tablets equivalent to 140 micrograms for 10 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Insulin secretion and insulin resistance
Time Frame: 6 hours
|
6 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Glycemic control, lipid status, inflammatory markers, BMD
Time Frame: 2 months
|
2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Lotte Oeskov, MD, Medical Department, Silkeborg Hospital, Falkevej 1-3, 8600 Silkeborg, Denmark
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2008
Primary Completion (Actual)
June 1, 2010
Study Completion (Actual)
June 1, 2010
Study Registration Dates
First Submitted
December 19, 2008
First Submitted That Met QC Criteria
December 19, 2008
First Posted (Estimate)
December 22, 2008
Study Record Updates
Last Update Posted (Estimate)
July 12, 2010
Last Update Submitted That Met QC Criteria
July 9, 2010
Last Verified
July 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UKO-1006-2008
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.