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Glucose Metabolism Effects of Vitamin D Supplementation in Prediabetes (VitDmet)

This study has been completed.
Sponsor:
Collaborators:
Academy of Finland
Juho Vainio Foundation
Finnish Foundation for Cardiovascular Research
Diabetes Research Foundation, Finland
Information provided by (Responsible Party):
Tomi-Pekka Tuomainen, University of Eastern Finland
ClinicalTrials.gov Identifier:
NCT01479933
First received: August 29, 2011
Last updated: March 3, 2013
Last verified: March 2013

August 29, 2011
March 3, 2013
September 2011
May 2012   (final data collection date for primary outcome measure)
Insulin sensitivity [ Time Frame: Six months ] [ Designated as safety issue: No ]
Change in insulin sensitivity measured by oral glucose tolerance test at baseline and after 6 months
Same as current
Complete list of historical versions of study NCT01479933 on ClinicalTrials.gov Archive Site
  • Peripheral blood mononuclear cell gene expression [ Time Frame: Six months ] [ Designated as safety issue: No ]
  • Inflammation [ Time Frame: Baseline to six months ] [ Designated as safety issue: No ]
    Change in inflammation measured as serum cytokines and adipose tissue inflammation at baseline and after 6 months
  • Adipose tissue gene expression [ Time Frame: Six months ] [ Designated as safety issue: No ]
  • Peripheral blood mononuclear cell gene expression [ Time Frame: Six months ] [ Designated as safety issue: No ]
  • Inflammation [ Time Frame: Six months ] [ Designated as safety issue: No ]
    Change in inflammation measured as serum cytokines and adipose tissue inflammation at baseline and after 6 months
  • Adipose tissue gene expression [ Time Frame: Six months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Glucose Metabolism Effects of Vitamin D Supplementation in Prediabetes
Randomized Controlled Trial of Vitamin D Supplementation on Glucose Metabolism in Subjects With Components of the Metabolic Syndrome

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
  • Prediabetic State
  • Overweight
  • Obese
  • Dietary Supplement: Vitamin D3
    Vitamin D3 40 micrograms (1600 IU) per day
  • Dietary Supplement: Placebo
    Inactive placebo
  • Dietary Supplement: Vitamin D 80
    Vitamin D3 80 micrograms (3200 IU) per day
  • Experimental: Vitamin D 40
    Vitamin D3 40 micrograms (1600 IU) per day
    Intervention: Dietary Supplement: Vitamin D3
  • Experimental: Vitamin D 80
    Vitamin D3 80 micrograms (3200 IU) per day
    Intervention: Dietary Supplement: Vitamin D 80
  • Placebo Comparator: Placebo
    Intervention: Dietary Supplement: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
73
May 2012
May 2012   (final data collection date for primary outcome measure)

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.
Both
60 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT01479933
VitDmet
No
Tomi-Pekka Tuomainen, University of Eastern Finland
University of Eastern Finland
  • Academy of Finland
  • Juho Vainio Foundation
  • Finnish Foundation for Cardiovascular Research
  • Diabetes Research Foundation, Finland
Principal Investigator: Tomi-Pekka Tuomainen, MD, PhD University of Eastern Finland
University of Eastern Finland
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP