University of Eastern Finland, Kuopio Campus
Kuopio, 70211, Finland
NCT Number: NCT01479933
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.
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Notify Me60 year and older
All sexes
Interventional
Not applicable
Kuopio, 70211, Finland
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Vitamin D3 40 micrograms (1600 IU) per day
Inactive placebo
Vitamin D3 80 micrograms (3200 IU) per day
Time frame: Six months
Change in insulin sensitivity measured by oral glucose tolerance test at baseline and after 6 months
Time frame: Six months
Time frame: Baseline to six months
Change in inflammation measured as serum cytokines and adipose tissue inflammation at baseline and after 6 months
Time frame: Six months
University of Eastern Finland
Other
Randomized Controlled Trial of Vitamin D Supplementation on Glucose Metabolism in Subjects With Components of the Metabolic Syndrome
Acronym: VitDmet
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