Overweight Clinical Trial
Official title:
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
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