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

Phase 4

Completed

• Conditions: Immune Tolerance
• Interventions: Drug: Cholecalciferol

• Registration Number: NCT01538485
• Lead Sponsor: Medical University of Graz

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.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-02-08
• Study First Submitted QC: 2012-02-20
• Study First Posted: 2012-02-24
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-09
• Last Update Posted: 2012-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• 18-40 years
• non smoker
• BMI: 20-30 kg/m²
• Healthy

Exclusion Criteria

• hypercalcemia > 2,65 mmol/L
• pregnancy
• chronic diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cholecalciferol	Cholecalciferol	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
other immune cells in the gastrointestinal mucosa	2 months
serum calcium level	2 months

Trial Locations

Locations (1)

Medical university Graz; 🇦🇹 Graz, Austria