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Vitamin D for the Prevention of Diabetes Type 2

This study has been completed.
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: September 18, 2015
Last verified: September 2015
  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
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

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 ]

Secondary Outcome Measures:
  • change in glucose metabolism [ Time Frame: 5 years ]
  • change in lipid status [ Time Frame: 5 years ]
  • change in mood [ Time Frame: 5 years ]
  • change in BMD hip [ Time Frame: 5 years ]
  • change in intima media thickness carotid artery [ Time Frame: 5 years ]
  • change in frequency of infections [ Time Frame: 5 years ]
  • change in blood pressure [ Time Frame: 5 years ]
  • Change in Insulin sensitivity [ Time Frame: 5 years ]
  • change in HbA1c [ Time Frame: 5 years ]
  • change in weight [ Time Frame: 5 years ]
  • change in telomer length [ Time Frame: 5 years ]

Other Outcome Measures:
  • 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


Enrollment: 511
Study Start Date: March 2008
Study Completion Date: September 2015
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

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: September 18, 2015

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

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

ClinicalTrials.gov processed this record on August 22, 2017