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Completed

NCT Number: NCT00685594

Vitamin D for the Prevention of Diabetes Type 2

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.

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Key information

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of Tromso

Tromsø, 9037, Norway

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Impaired glucose tolerance

Exclusion criteria

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

Treatment and study plan

Cholecalciferol

Drug

20.000 IU cholecalciferol per week for 5 years versus placebo

Other names: vitamin D

Placebo

Drug

Placebo capsule once a week, identical to cholecalciferol capsule

Primary outcomes

  1. development of diabetes type 2

    Time frame: 5 years

Secondary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Tromso

Other

Collaborators

  • University Hospital of North Norway

Registry information

Official study title

Prevention of Type 2 Diabetes With Vitamin D Supplementation in Subjects With Reduced Glucose Tolerance Detected in the Tromso Study 2007/2008

Important dates

Study start
2008
Primary completion
2015
Study completion
2015
First posted
May 28, 2008
Registry last updated
Sep 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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