Immune and Metabolic Effects of Vitamin D Supplementation in Healthy Humans

Healthy Humans Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01248442
• Other study ID #: ENM-EA-011
• Status: Completed
• Phase: Phase 4
• First received: November 24, 2010
• Last updated: February 8, 2012
• Start date: November 2009
• Est. completion date: June 2010

Study information

• Verified date: February 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 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Healthy Humans

Intervention

Drug:
• Cholecalciferol
monthly dose of 140.000 IU of cholecalciferol orally, 3 times.
• Placebo
Matching Placebo

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 and function of peripheral regulatory T-cells	The level and function of the regulatory T-cells will be compared between the two groups.	3 months	No
Secondary	immunophenotyping	The effect of vitamin D on circulating immune cells and cytokine secretion will be measured at basal and after 3 months.	3 months	No
Secondary	Renin and aldosterone concentrations	serum renin and aldosterone levels will be measured basal and after 3 months.	3 months	No
Secondary	Insulin secretion	Insulin secretion assessed with a mixed meal tolerance test will be performed basal and after 3 months	3 months	No
Secondary	calcium levels	serum calcium levels will be measured basal and monthly for 3 months.	3 months	Yes