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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01538485
Other study ID # ADPP 003: GUT
Secondary ID
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


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
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