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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01538485
First Posted: February 24, 2012
Last Update Posted: October 10, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Medical University of Graz
  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: Intervention Model: Single Group Assignment
Masking: None (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 ]
    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 ]
  • serum calcium level [ Time Frame: 2 months ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT01538485     History of Changes
Other Study ID Numbers: ADPP 003: GUT
First Submitted: February 8, 2012
First Posted: February 24, 2012
Last Update Posted: October 10, 2012
Last Verified: October 2012

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

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