Immune Tolerance Clinical Trial
Official title:
Pilot Study to Assess the Effects of Vitamin D Supplementation on the Number of Regulatory FoxP3+ T Cells in the Gastrointestinal Mucosa in Healthy Women and Men: Step 3 in the Austrian Diabetes Prevention Programme
In this pilot study the investigators aim to investigate the effects of vitamin D supplementation on regulatory FoxP3+ T cells in the gastrointestinal mucosa in healthy women and men.
This is a monocentric, open pilot study, with the aim to evaluate the effect of vitamin d
supplementation on regulatory FoxP3+ T cells in the gastrointestinal mucosa in healthy women
and men.
The primary goal is to evaluate the influence of vitamin D supplementation on the regulatory
FoxP3+ T cells in the gastrointestinal mucosa under controlled conditions within 2 months.
The secondary study goals are to evaluate the effect of vitamin D supplementation on
peripheral induced tregs and on other important immune cells in the tissue (NK, NKT cells
and LPCD) and in the blood (NK, NKT cells, Th17, Th1, Th2 cells) within 2 months.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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