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

February 8, 2012
October 9, 2012
January 2012
August 2012   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01538485 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Vitamin D Supplementation and Regulatory FoxP3+ T Cells in the GUT
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

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.

Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Immune Tolerance
Drug: Cholecalciferol
weekly dose (based on 70IU KG body weight/day)
Other Name: Oleovit D3
Experimental: Cholecalciferol
Intervention: Drug: Cholecalciferol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
August 2012
August 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • hypercalcemia > 2,65 mmol/L
  • pregnancy
  • chronic diseases
Both
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT01538485
ADPP 003: GUT
Yes
Medical University of Graz
Medical University of Graz
Not Provided
Principal Investigator: Thomas R. Pieber, Prof. Medical University of Graz
Medical University of Graz
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP