Immune and Metabolic Effects of Vitamin D Supplementation in Healthy Humans
|ClinicalTrials.gov Identifier: NCT01248442|
Recruitment Status : Completed
First Posted : November 25, 2010
Last Update Posted : February 9, 2012
|Condition or disease||Intervention/treatment||Phase|
|Healthy Humans||Drug: Cholecalciferol Drug: Placebo||Phase 4|
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 (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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.|
|Study Start Date :||November 2009|
|Actual Primary Completion Date :||June 2010|
|Actual Study Completion Date :||June 2010|
monthly dose of 140.000 IU of cholecalciferol orally, 3 times.
Other Name: Oleovit D3
|Placebo Comparator: Placebo||
Other Name: Almondoil
- Increase and function of peripheral regulatory T-cells [ Time Frame: 3 months ]The level and function of the regulatory T-cells will be compared between the two groups.
- immunophenotyping [ Time Frame: 3 months ]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 ]serum renin and aldosterone levels will be measured basal and after 3 months.
- Insulin secretion [ Time Frame: 3 months ]Insulin secretion assessed with a mixed meal tolerance test will be performed basal and after 3 months
- calcium levels [ Time Frame: 3 months ]serum calcium levels will be measured basal and monthly for 3 months.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01248442
|Medical University Graz|
|Graz, Austria, 8036|
|Principal Investigator:||Thomas R Pieber, Prof.||Medical University of Graz|