Immune and Metabolic Effects of Vitamin D Supplementation in Healthy Humans

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medical University of Graz
ClinicalTrials.gov Identifier:
NCT01248442
First received: November 24, 2010
Last updated: February 8, 2012
Last verified: February 2012

November 24, 2010
February 8, 2012
November 2009
June 2010   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01248442 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Immune and Metabolic Effects of Vitamin D Supplementation in Healthy Humans
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Healthy Humans
  • Drug: Cholecalciferol
    monthly dose of 140.000 IU of cholecalciferol orally, 3 times.
    Other Name: Oleovit D3
  • Drug: Placebo
    Matching Placebo
    Other Name: Almondoil
  • Experimental: Cholecalciferol
    Intervention: Drug: Cholecalciferol
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
June 2010
June 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT01248442
ENM-EA-011
Yes
Medical University of Graz
Medical University of Graz
Not Provided
Principal Investigator: Thomas R Pieber, Prof. Medical University of Graz
Medical University of Graz
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP