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

Medical University of Graz

Status and phase: Completed; Phase 4

Conditions: Immune Tolerance

Treatments: Drug: Cholecalciferol

Study type: Interventional

Funder types: Other

Identifiers

NCT01538485

ADPP 003: GUT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Cholecalciferol

Experimental group

Treatment:

Drug: Cholecalciferol