Vitamin D for the Prevention of Diabetes Type 2

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University Hospital of North Norway
Information provided by (Responsible Party):
University of Tromso
ClinicalTrials.gov Identifier:
NCT00685594
First received: May 9, 2008
Last updated: August 16, 2013
Last verified: August 2013

May 9, 2008
August 16, 2013
March 2008
March 2015   (final data collection date for primary outcome measure)
development of diabetes type 2 [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00685594 on ClinicalTrials.gov Archive Site
  • change in glucose metabolism [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • change in lipid status [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • change in mood [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • change in BMD hip [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • change in intima media thickness carotid artery [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • change in frequency of infections [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • change in blood pressure [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Change in Insulin sensitivity [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • change in HbA1c [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • change in weight [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • change in telomer length [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • change in glucose metabolism [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • change in lipid status [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • change in mood [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • change in BMD hip [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • change in intima media thickness carotid artery [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • change in frequency of infections [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • change in blood pressure [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Oral glucose tolerance response to vitamin D supplementation in relation to polymorphisms in the vitamin D system [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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
Not Provided
 
Vitamin D for the Prevention of Diabetes Type 2
Prevention of Type 2 Diabetes With Vitamin D Supplementation in Subjects With Reduced Glucose Tolerance Detected in the Tromso Study 2007/2008

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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Impaired Glucose Tolerance
  • Drug: cholecalciferol
    20.000 IU cholecalciferol per week for 5 years versus placebo
    Other Name: vitamin D
  • Drug: Placebo
    Placebo capsule once a week, identical to cholecalciferol capsule
    Other Name: Placebo
  • Experimental: 1
    Cholecalciferol 20.000 IU per week for 5 years
    Intervention: Drug: cholecalciferol
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
600
March 2016
March 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Impaired glucose tolerance

Exclusion Criteria:

  • Serious heart disease
  • Renal stone disease
  • Hypercalcemia
  • Sarcoidosis
Both
21 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00685594
UIT-ENDO-2008-1, NFR 184766/V50
Yes
University of Tromso
University of Tromso
University Hospital of North Norway
Principal Investigator: Rolf Jorde, Professor University of Tromso
University of Tromso
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP