Vitamin D for the Prevention of Diabetes Type 2
Primary Purpose
Impaired Glucose Tolerance
Status
Completed
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
cholecalciferol
Placebo
Sponsored by

About this trial
This is an interventional prevention trial for Impaired Glucose Tolerance focused on measuring diabetes, vitamin D, cholecalciferol, glucose tolerance
Eligibility Criteria
Inclusion Criteria:
- Impaired glucose tolerance
Exclusion Criteria:
- Serious heart disease
- Renal stone disease
- Hypercalcemia
- Sarcoidosis
Sites / Locations
- University of Tromso
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Cholecalciferol 20.000 IU per week for 5 years
Outcomes
Primary Outcome Measures
development of diabetes type 2
Secondary Outcome Measures
change in glucose metabolism
change in lipid status
change in mood
change in BMD hip
change in intima media thickness carotid artery
change in frequency of infections
change in blood pressure
Change in Insulin sensitivity
change in HbA1c
change in weight
change in telomer length
Full Information
NCT ID
NCT00685594
First Posted
May 9, 2008
Last Updated
September 18, 2015
Sponsor
University of Tromso
Collaborators
University Hospital of North Norway
1. Study Identification
Unique Protocol Identification Number
NCT00685594
Brief Title
Vitamin D for the Prevention of Diabetes Type 2
Official Title
Prevention of Type 2 Diabetes With Vitamin D Supplementation in Subjects With Reduced Glucose Tolerance Detected in the Tromso Study 2007/2008
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Tromso
Collaborators
University Hospital of North Norway
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The prevalence of type 2 diabetes is increasing, which for most societies has considerable consequences not only regarding health but also economy. Type 2 diabetes develops through a "prediabetic" stage with impaired glucose tolerance. Intervention at this stage with change in lifestyle or with medication may prevent such progression. There are indications that vitamin D is of importance in glucose metabolism, and that supplementation with vitamin D may increase both insulin secretion and insulin sensitivity. Accordingly, supplementation with vitamin D may improve glucose tolerance and potentially prevent the development of type 2 diabetes in subjects at risk. However, this has so far not been demonstrated in a prospective, randomised clinical study. In the present study we will therefore include 600 subjects with impaired glucose tolerance (or impaired fasting glucose) detected in the Tromso study 2007/2008 and randomize to supplementation with vitamin D 20.000IU per week or placebo for 5 years. A glucose tolerance test will be performed each year, and development of type 2 diabetes will be the main endpoint.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impaired Glucose Tolerance
Keywords
diabetes, vitamin D, cholecalciferol, glucose tolerance
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
511 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Cholecalciferol 20.000 IU per week for 5 years
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
cholecalciferol
Other Intervention Name(s)
vitamin D
Intervention Description
20.000 IU cholecalciferol per week for 5 years versus placebo
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo capsule once a week, identical to cholecalciferol capsule
Primary Outcome Measure Information:
Title
development of diabetes type 2
Time Frame
5 years
Secondary Outcome Measure Information:
Title
change in glucose metabolism
Time Frame
5 years
Title
change in lipid status
Time Frame
5 years
Title
change in mood
Time Frame
5 years
Title
change in BMD hip
Time Frame
5 years
Title
change in intima media thickness carotid artery
Time Frame
5 years
Title
change in frequency of infections
Time Frame
5 years
Title
change in blood pressure
Time Frame
5 years
Title
Change in Insulin sensitivity
Time Frame
5 years
Title
change in HbA1c
Time Frame
5 years
Title
change in weight
Time Frame
5 years
Title
change in telomer length
Time Frame
5 years
Other Pre-specified Outcome Measures:
Title
Oral glucose tolerance response to vitamin D supplementation in relation to polymorphisms in the vitamin D system
Description
The response to oral glucose tolerance test (fasting and 2 h blood glucose, serum insulin, C-peptide, measures of insulin resistiance as well as metabolic parameters (lipids, blood pressure)) will be evaluated in the results at the 1-year visit in relation to genetic polymorphisms in the vitamin D system
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Impaired glucose tolerance
Exclusion Criteria:
Serious heart disease
Renal stone disease
Hypercalcemia
Sarcoidosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rolf Jorde, Professor
Organizational Affiliation
University of Tromso
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Tromso
City
Tromso
ZIP/Postal Code
9037
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
26829443
Citation
Jorde R, Sollid ST, Svartberg J, Schirmer H, Joakimsen RM, Njolstad I, Fuskevag OM, Figenschau Y, Hutchinson MY. Vitamin D 20,000 IU per Week for Five Years Does Not Prevent Progression From Prediabetes to Diabetes. J Clin Endocrinol Metab. 2016 Apr;101(4):1647-55. doi: 10.1210/jc.2015-4013. Epub 2016 Feb 1.
Results Reference
derived
Learn more about this trial
Vitamin D for the Prevention of Diabetes Type 2
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