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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 21, 2014