Immune Tolerance
Conditions
Keywords
Vitamin D, regulatory T cells, GUT
Brief summary
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.
Detailed description
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.
Interventions
DRUGCholecalciferol
weekly dose (based on 70IU KG body weight/day)
Sponsors
Medical University of Graz
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* 18-40 years * non smoker * BMI: 20-30 kg/m² * Healthy
Exclusion criteria
* hypercalcemia \> 2,65 mmol/L * pregnancy * chronic diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Increase of regulatory FOXP3+ T cells | 2 months | the effects of vitamin D on regulatory FOXP3+ T cells will be measured at basal and after 2 months |
Secondary
| Measure | Time frame |
|---|---|
| other immune cells in the gastrointestinal mucosa | 2 months |
| serum calcium level | 2 months |
Countries
Austria
Outcome results
None listed