Healthy Humans Clinical Trial
Official title:
Placebo Controlled Study to Assess the Effects of Vitamin D Supplementation on Parameters of the Immune, Endocrine and Metabolic System in Healthy Women and Men.
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
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