Immune and Metabolic Effects of Vitamin D Supplementation in Healthy Humans

Medical University of Graz60 enrolled

Overview

In this placebo controlled study the investigators aim to investigate the effect of a 3 month vitamin D supplementation on parameters of the immune, endocrine and metabolic system in healthy women and men. Vitamin D. In a pilot study the investigators showed an increase of certain immune cells, which regulate immunotolerance, the investigators therefore try to confirm these results with a placebo group. Furthermore the investigators assess the effect of vitamin D on the glucose metabolism and hormone levels.

This is a randomized double-blind placebo controlled trial, with the aim to investigate the effect of a Vitamin D supplementation on parameters of the immune, endocrine and metabolic system in healthy humans without diabetes and obesity. The primary aim is to assess the effect of vitamin D supplementation of the number and function of peripheral regulatory T-cells (Tregs). The investigators will measure the Tregs at baseline and monthly for 3 months. Furthermore the investigators assess additional immune cells from the adaptive immunosystem. Furthermore the investigators will perform a standard mixed meal tolerance test at baseline and 3 months following the supplementation in order to assess the insulin secretion in vivo.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Healthy Humans

Interventions

CholecalciferolDRUG

monthly dose of 140.000 IU of cholecalciferol orally, 3 times.

PlaceboDRUG

Matching Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Age \>= 10 years * healthy subjects without chronic disease Exclusion Criteria: * Hypercalcemia \>2,65 mmol/L * pregnancy and lactation period * acute infections * chronic disease requiring treatment

Locations (1)

Medical University Graz

Graz, Austria

Outcomes

Primary Outcomes

Increase and function of peripheral regulatory T-cells

The level and function of the regulatory T-cells will be compared between the two groups.

Time frame: 3 months

Secondary Outcomes

immunophenotyping

The effect of vitamin D on circulating immune cells and cytokine secretion will be measured at basal and after 3 months.

Time frame: 3 months

Renin and aldosterone concentrations

serum renin and aldosterone levels will be measured basal and after 3 months.

Time frame: 3 months

Insulin secretion

Insulin secretion assessed with a mixed meal tolerance test will be performed basal and after 3 months

Time frame: 3 months

calcium levels

serum calcium levels will be measured basal and monthly for 3 months.

Time frame: 3 months

Data from ClinicalTrials.gov

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