A Phase 4 interventional study of Cholecalciferol and Placebo in Healthy Humans, sponsored by Medical University of Graz. Completed at 1 site in Austria. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-02-09.
Sponsored by Medical University of Graz · Phase 4, Interventional, and Prevention
In this placebo controlled study the investigators aim to investigate the effect of a 3 month vitamin D supplementation on parameters of the immune, endocrine and metabolic system in healthy women and men. Vitamin D. In a pilot study the investigators showed an increase of certain immune cells, which regulate immunotolerance, the investigators therefore try to confirm these results with a placebo group. Furthermore the investigators assess the effect of vitamin D on the glucose metabolism and hormone levels.
This is a randomized double-blind placebo controlled trial, with the aim to investigate the effect of a Vitamin D supplementation on parameters of the immune, endocrine and metabolic system in healthy humans without diabetes and obesity.
The primary aim is to assess the effect of vitamin D supplementation of the number and function of peripheral regulatory T-cells (Tregs). The investigators will measure the Tregs at baseline and monthly for 3 months. Furthermore the investigators assess additional immune cells from the adaptive immunosystem.
Furthermore the investigators will perform a standard mixed meal tolerance test at baseline and 3 months following the supplementation in order to assess the insulin secretion in vivo.
Medical University of Graz is the lead sponsor of 459 studies on the registry; 98 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Cholecalciferol
Drug: Placebo
monthly dose of 140.000 IU of cholecalciferol orally, 3 times.
Also known as: Oleovit D3
Matching Placebo
Also known as: Almondoil
Increase and function of peripheral regulatory T-cells
The level and function of the regulatory T-cells will be compared between the two groups.
Time frame: 3 months
immunophenotyping
The effect of vitamin D on circulating immune cells and cytokine secretion will be measured at basal and after 3 months.
Time frame: 3 months
Renin and aldosterone concentrations
serum renin and aldosterone levels will be measured basal and after 3 months.
Time frame: 3 months
Insulin secretion
Insulin secretion assessed with a mixed meal tolerance test will be performed basal and after 3 months
Time frame: 3 months
calcium levels
serum calcium levels will be measured basal and monthly for 3 months.
Time frame: 3 months
This study is completed, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.
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Medical University of Graz