Trial | NCT01479933  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    vitamin d3 ...

  • Study Participants

    73
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.
Study Started
Sep 30
2011
Primary Completion
May 31
2012
Study Completion
May 31
2012
Last Update
Mar 05
2013
Estimate

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

Vitamin D 40 Experimental

Vitamin D3 40 micrograms (1600 IU) per day

Vitamin D 80 Experimental

Vitamin D3 80 micrograms (3200 IU) per day

Placebo Placebo Comparator

Criteria 

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.
No Results Posted