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Completed

NCT Number: NCT01538485

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

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.

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Key information

Conditions

Immune Tolerance

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Medical university Graz

Graz, 8020, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Cholecalciferol

Drug

weekly dose (based on 70IU KG body weight/day)

Other names: Oleovit D3

Primary outcomes

  1. 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 outcomes

  1. other immune cells in the gastrointestinal mucosa

    Time frame: 2 months

  2. serum calcium level

    Time frame: 2 months

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Feb 24, 2012
Registry last updated
Oct 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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