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

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ClinicalTrials.gov Identifier: NCT01479933
Recruitment Status : Completed
First Posted : November 28, 2011
Last Update Posted : March 5, 2013
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

Tracking Information
First Submitted Date  ICMJE August 29, 2011
First Posted Date  ICMJE November 28, 2011
Last Update Posted Date March 5, 2013
Study Start Date  ICMJE September 2011
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 22, 2011)
Insulin sensitivity [ Time Frame: Six months ]
Change in insulin sensitivity measured by oral glucose tolerance test at baseline and after 6 months
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 3, 2013)
  • Peripheral blood mononuclear cell gene expression [ Time Frame: Six months ]
  • Inflammation [ Time Frame: Baseline to six months ]
    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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 22, 2011)
  • Peripheral blood mononuclear cell gene expression [ Time Frame: Six months ]
  • Inflammation [ Time Frame: Six months ]
    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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Glucose Metabolism Effects of Vitamin D Supplementation in Prediabetes
Official Title  ICMJE Randomized Controlled Trial of Vitamin D Supplementation on Glucose Metabolism in Subjects With Components of the Metabolic Syndrome
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE
  • Prediabetic State
  • Overweight
  • Obese
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Ryynänen J, Neme A, Tuomainen TP, Virtanen JK, Voutilainen S, Nurmi T, de Mello VD, Uusitupa M, Carlberg C. Changes in vitamin D target gene expression in adipose tissue monitor the vitamin D response of human individuals. Mol Nutr Food Res. 2014 Oct;58(10):2036-45. doi: 10.1002/mnfr.201400291. Epub 2014 Jul 28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 3, 2013)
73
Original Estimated Enrollment  ICMJE
 (submitted: November 22, 2011)
102
Actual Study Completion Date  ICMJE May 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01479933
Other Study ID Numbers  ICMJE VitDmet
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tomi-Pekka Tuomainen, University of Eastern Finland
Study Sponsor  ICMJE University of Eastern Finland
Collaborators  ICMJE
  • Academy of Finland
  • Juho Vainio Foundation
  • Finnish Foundation for Cardiovascular Research
  • Diabetes Research Foundation, Finland
Investigators  ICMJE
Principal Investigator: Tomi-Pekka Tuomainen, MD, PhD University of Eastern Finland
PRS Account University of Eastern Finland
Verification Date March 2013

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