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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01538485
• Other study ID #: ADPP 003: GUT
• Status: Completed
• Phase: Phase 4
• First received: February 8, 2012
• Last updated: October 9, 2012
• Start date: January 2012
• Est. completion date: August 2012

Study information

• Verified date: October 2012
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Office for Safety in Health Care
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Immune Tolerance

Intervention

Drug:
• Cholecalciferol
weekly dose (based on 70IU KG body weight/day)

Locations

Country	Name	City	State
Austria	Medical university Graz	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	2 months	No
Secondary	other immune cells in the gastrointestinal mucosa		2 months	No
Secondary	serum calcium level		2 months	Yes