Vitamin D for the Prevention of Diabetes Type 2

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00685594
Recruitment Status : Completed
First Posted : May 28, 2008
Last Update Posted : September 22, 2015
University Hospital of North Norway
Information provided by (Responsible Party):
University of Tromso

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.

Condition or disease Intervention/treatment Phase
Impaired Glucose Tolerance Drug: cholecalciferol Drug: Placebo Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 511 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
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 Start Date : March 2008
Actual Primary Completion Date : March 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Arm Intervention/treatment
Experimental: 1
Cholecalciferol 20.000 IU per week for 5 years
Drug: cholecalciferol
20.000 IU cholecalciferol per week for 5 years versus placebo
Other Name: vitamin D

Placebo Comparator: 2 Drug: Placebo
Placebo capsule once a week, identical to cholecalciferol capsule

Primary Outcome Measures :
  1. development of diabetes type 2 [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. change in glucose metabolism [ Time Frame: 5 years ]
  2. change in lipid status [ Time Frame: 5 years ]
  3. change in mood [ Time Frame: 5 years ]
  4. change in BMD hip [ Time Frame: 5 years ]
  5. change in intima media thickness carotid artery [ Time Frame: 5 years ]
  6. change in frequency of infections [ Time Frame: 5 years ]
  7. change in blood pressure [ Time Frame: 5 years ]
  8. Change in Insulin sensitivity [ Time Frame: 5 years ]
  9. change in HbA1c [ Time Frame: 5 years ]
  10. change in weight [ Time Frame: 5 years ]
  11. change in telomer length [ Time Frame: 5 years ]

Other Outcome Measures:
  1. Oral glucose tolerance response to vitamin D supplementation in relation to polymorphisms in the vitamin D system [ Time Frame: 1 year ]
    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

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Impaired glucose tolerance

Exclusion Criteria:

  • Serious heart disease
  • Renal stone disease
  • Hypercalcemia
  • Sarcoidosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00685594

University of Tromso
Tromso, Norway, 9037
Sponsors and Collaborators
University of Tromso
University Hospital of North Norway
Principal Investigator: Rolf Jorde, Professor University of Tromso

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University of Tromso Identifier: NCT00685594     History of Changes
Other Study ID Numbers: UIT-ENDO-2008-1
NFR 184766/V50
First Posted: May 28, 2008    Key Record Dates
Last Update Posted: September 22, 2015
Last Verified: September 2015

Keywords provided by University of Tromso:
vitamin D
glucose tolerance

Additional relevant MeSH terms:
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents