Skip to main content
OpenTrials
Completed

NCT Number: NCT01479933

Glucose Metabolism Effects of Vitamin D Supplementation in Prediabetes

Vitamin D deficiency is widespread throughout the world, and the deficiency has been associated with several chronic diseases, such as cardiovascular diseases and diabetes. In Nordic countries, like in Finland, there is a particular variation in vitamin D status, and during wintertime, when there is no exposure to ultraviolet-B light from the sun, serum concentrations of vitamin D decrease substantially. In Finland, some 40% of middle-aged men and one third of women also have some degree of impairment of glucose metabolism.

The purpose of this trial is to investigate the effects of two different daily doses of vitamin D on glucose metabolism in men 60 years of age or older and who are vitamin D deficient, have a high body mass index and at least two characteristics of cardio-metabolic syndrome.

Altogether 102 subjects with low serum calcidiol (<60 nmol/L) will be recruited and randomized to one of the three groups: 1) 40 µg/d vitamin D3, 2) 80 µg/d vitamin D3 or 3) placebo. The supplementation period will last for 6 months from September 2011 to March 2012.

The main hypotheses of the trial are: (1.) Vitamin D supplementation will improve glucose and insulin metabolism in people with a low baseline vitamin D status, in a dose-dependent manner. (2.) Vitamin D supplementation will have an effect on the expression of genes involved in glucose and insulin metabolism and inflammation. (3.) Vitamin D supplementation will have an effect on epigenetic changes in key genes participating in vitamin D metabolism.

Completed

Looking for future studies?

Notify Me

Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Eastern Finland, Kuopio Campus

Kuopio, 70211, Finland

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 60 years or older
  • Serum calcidiol <75 nmol/L
  • Body mass index 25-35 kg/m2
  • Impaired fasting glucose or impaired glucose tolerance (fasting glucose 5.6-7.0 mmol/L or 2h oral glucose tolerance test glucose 7.8-11.0 mmol/L)

Exclusion criteria

  • Any chronic disease and condition, which may hamper to follow the intervention protocol (such as alcohol abuse)
  • Any chronic disease or therapy which may mask or interact with the investigated effects (such as diabetes or systemic corticosteroid therapy)
  • Any disease or state that raises a vitamin D related safety concern (such as chronic liver, thyroid or kidney disease, hypercalcemia, sarcoidosis or other granulomatous diseases such as active chronic tuberculosis or Wegener's granulomatosis)
  • Use of supplements yielding vitamin D over 20 µg/d and unwillingness to discontinue the use.

Treatment and study plan

Vitamin D3

Dietary Supplement

Vitamin D3 40 micrograms (1600 IU) per day

Placebo

Dietary Supplement

Inactive placebo

Vitamin D 80

Dietary Supplement

Vitamin D3 80 micrograms (3200 IU) per day

Primary outcomes

  1. Insulin sensitivity

    Time frame: Six months

    Change in insulin sensitivity measured by oral glucose tolerance test at baseline and after 6 months

Secondary outcomes

  1. Peripheral blood mononuclear cell gene expression

    Time frame: Six months

  2. Inflammation

    Time frame: Baseline to six months

    Change in inflammation measured as serum cytokines and adipose tissue inflammation at baseline and after 6 months

  3. Adipose tissue gene expression

    Time frame: Six months

Sponsors and collaborators

Lead sponsor

University of Eastern Finland

Other

Collaborators

  • Academy of Finland
  • Diabetes Research Foundation, Finland
  • Finnish Foundation for Cardiovascular Research
  • Juho Vainio Foundation

Registry information

Official study title

Randomized Controlled Trial of Vitamin D Supplementation on Glucose Metabolism in Subjects With Components of the Metabolic Syndrome

Acronym: VitDmet

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Nov 28, 2011
Registry last updated
Mar 5, 2013

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.

Published trials that share one or more normalized conditions with this study.