Immune and Metabolic Effects of Vitamin D Supplementation in Healthy Humans
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
|Official Title:||Placebo Controlled Study to Assess the Effects of Vitamin D Supplementation on Parameters of the Immune, Endocrine and Metabolic System in Healthy Women and Men.|
- Increase and function of peripheral regulatory T-cells [ Time Frame: 3 months ] [ Designated as safety issue: No ]The level and function of the regulatory T-cells will be compared between the two groups.
- immunophenotyping [ Time Frame: 3 months ] [ Designated as safety issue: No ]The effect of vitamin D on circulating immune cells and cytokine secretion will be measured at basal and after 3 months.
- Renin and aldosterone concentrations [ Time Frame: 3 months ] [ Designated as safety issue: No ]serum renin and aldosterone levels will be measured basal and after 3 months.
- Insulin secretion [ Time Frame: 3 months ] [ Designated as safety issue: No ]Insulin secretion assessed with a mixed meal tolerance test will be performed basal and after 3 months
- calcium levels [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]serum calcium levels will be measured basal and monthly for 3 months.
|Study Start Date:||November 2009|
|Study Completion Date:||June 2010|
|Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
monthly dose of 140.000 IU of cholecalciferol orally, 3 times.
Other Name: Oleovit D3
|Placebo Comparator: Placebo||
Other Name: Almondoil
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01248442
|Medical University Graz|
|Graz, Austria, 8036|
|Principal Investigator:||Thomas R Pieber, Prof.||Medical University of Graz|