Metabolic Effects of Vitamin D in Patients With Type 2 Diabetes (ProjectD)
Primary Purpose
Type 2 Diabetes, Vitamin D Insufficiency
Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Cholecalciferol
Sponsored by

About this trial
This is an interventional basic science trial for Type 2 Diabetes focused on measuring Type 2 diabetes, Vitamin D insufficiency, Insulin secretion, Insulin sensitivity, Pulsatility
Eligibility 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
Sites / Locations
- Medical Research Unit, Medical Department M, Aarhus University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Cholecalciferol
Placebo pill
Arm Description
Outcomes
Primary Outcome Measures
Insulin secretion and insulin resistance
Secondary Outcome Measures
Glycemic control, lipid status, inflammatory markers, BMD
Full Information
NCT ID
NCT00812578
First Posted
December 19, 2008
Last Updated
July 9, 2010
Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital, Regionshospitalet Silkeborg
1. Study Identification
Unique Protocol Identification Number
NCT00812578
Brief Title
Metabolic Effects of Vitamin D in Patients With Type 2 Diabetes
Acronym
ProjectD
Official Title
Metabolic Effects of Vitamin D in Patients With Type 2 Diabetes - a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital, Regionshospitalet Silkeborg
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Vitamin D Insufficiency
Keywords
Type 2 diabetes, Vitamin D insufficiency, Insulin secretion, Insulin sensitivity, Pulsatility
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cholecalciferol
Arm Type
Active Comparator
Arm Title
Placebo pill
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Cholecalciferol
Intervention Description
8 tablets equivalent to 280 micrograms for 2 weeks and 4 tablets equivalent to 140 micrograms for 10 weeks
Primary Outcome Measure Information:
Title
Insulin secretion and insulin resistance
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
Glycemic control, lipid status, inflammatory markers, BMD
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lotte Oeskov, MD
Organizational Affiliation
Medical Department, Silkeborg Hospital, Falkevej 1-3, 8600 Silkeborg, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Research Unit, Medical Department M, Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
25044176
Citation
Kampmann U, Mosekilde L, Juhl C, Moller N, Christensen B, Rejnmark L, Wamberg L, Orskov L. Effects of 12 weeks high dose vitamin D3 treatment on insulin sensitivity, beta cell function, and metabolic markers in patients with type 2 diabetes and vitamin D insufficiency - a double-blind, randomized, placebo-controlled trial. Metabolism. 2014 Sep;63(9):1115-24. doi: 10.1016/j.metabol.2014.06.008. Epub 2014 Jun 19.
Results Reference
derived
Learn more about this trial
Metabolic Effects of Vitamin D in Patients With Type 2 Diabetes
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