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
  Purpose

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 Intervention Phase
Impaired Glucose Tolerance
Drug: cholecalciferol
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by University of Tromso:

Primary Outcome Measures:
  • development of diabetes type 2 [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Other Outcome Measures:
  • 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


Estimated Enrollment: 600
Study Start Date: March 2008
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Placebo

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Impaired glucose tolerance

Exclusion Criteria:

  • Serious heart disease
  • Renal stone disease
  • Hypercalcemia
  • Sarcoidosis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00685594

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

No publications provided

Responsible Party: University of Tromso
ClinicalTrials.gov Identifier: NCT00685594     History of Changes
Other Study ID Numbers: UIT-ENDO-2008-1, NFR 184766/V50
Study First Received: May 9, 2008
Last Updated: August 16, 2013
Health Authority: Norway: Norwegian Medicines Agency

Keywords provided by University of Tromso:
diabetes
vitamin D
cholecalciferol
glucose tolerance

Additional relevant MeSH terms:
Glucose Intolerance
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on April 15, 2014