Vitamin D Supplementation and Regulatory FoxP3+ T Cells in the GUT
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|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|
- Increase of regulatory FOXP3+ T cells [ Time Frame: 2 months ] [ Designated as safety issue: No ]the effects of vitamin D on regulatory FOXP3+ T cells will be measured at basal and after 2 months
- other immune cells in the gastrointestinal mucosa [ Time Frame: 2 months ] [ Designated as safety issue: No ]
- serum calcium level [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2012|
|Study Completion Date:||August 2012|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
weekly dose (based on 70IU KG body weight/day)
Other Name: Oleovit D3
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01538485
|Medical university Graz|
|Graz, Austria, 8020|
|Principal Investigator:||Thomas R. Pieber, Prof.||Medical University of Graz|