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

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	Complete list of historical versions of study NCT01479933 on ClinicalTrials.gov Archive Site
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 Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	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	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	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	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	Sexes Eligible for Study: All
Ages	60 Years and older (Adult, Senior)
Accepts Healthy Volunteers	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	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