Vitamin D Supplementation and Regulatory FoxP3+ T Cells in the GUT

Medical University of Graz16 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Immune Tolerance

Interventions

CholecalciferolDRUG

weekly dose (based on 70IU KG body weight/day)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 18-40 years * non smoker * BMI: 20-30 kg/m² * Healthy Exclusion Criteria: * hypercalcemia \> 2,65 mmol/L * pregnancy * chronic diseases

Locations (1)

Medical university Graz

Graz, Austria

Outcomes

Primary Outcomes

Increase of regulatory FOXP3+ T cells

the effects of vitamin D on regulatory FOXP3+ T cells will be measured at basal and after 2 months

Time frame: 2 months

Secondary Outcomes

other immune cells in the gastrointestinal mucosa

Time frame: 2 months

serum calcium level

Time frame: 2 months

Data from ClinicalTrials.gov

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