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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medical University of Graz
ClinicalTrials.gov Identifier:
NCT01538485
First received: February 8, 2012
Last updated: October 9, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Immune Tolerance
Drug: Cholecalciferol
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Enrollment: 16
Study Start Date: January 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cholecalciferol Drug: Cholecalciferol
weekly dose (based on 70IU KG body weight/day)
Other Name: Oleovit D3

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • hypercalcemia > 2,65 mmol/L
  • pregnancy
  • chronic diseases
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01538485

Locations
Austria
Medical university Graz
Graz, Austria, 8020
Sponsors and Collaborators
Medical University of Graz
Investigators
Principal Investigator: Thomas R. Pieber, Prof. Medical University of Graz
  More Information

No publications provided

Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT01538485     History of Changes
Other Study ID Numbers: ADPP 003: GUT
Study First Received: February 8, 2012
Last Updated: October 9, 2012
Health Authority: Austria: Federal Office for Safety in Health Care

Keywords provided by Medical University of Graz:
Vitamin D
regulatory T cells
GUT

Additional relevant MeSH terms:
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on July 20, 2014