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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Healthy Humans
 Drug: Cholecalciferol
Drug: Placebo
 Phase 4

Study Type: Interventional
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 60
Study Start Date: November 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cholecalciferol Drug: Cholecalciferol
monthly dose of 140.000 IU of cholecalciferol orally, 3 times.
Other Name: Oleovit D3
Placebo Comparator: Placebo Drug: Placebo
Matching Placebo
Other Name: Almondoil

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01248442

Locations
Austria
Medical University Graz
Graz, Austria, 8036
Sponsors and Collaborators
Medical University of Graz
Investigators
Principal Investigator: Thomas R Pieber, Prof. Medical University of Graz
  More Information

No publications provided

Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT01248442     History of Changes
Other Study ID Numbers: ENM-EA-011
Study First Received: November 24, 2010
Last Updated: February 8, 2012
Health Authority: Austria: Federal Office for Safety in Health Care

Keywords provided by Medical University of Graz:
Vitamin D Deficiency
Autoimmune disease
Diabetes

Additional relevant MeSH terms:
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
 Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on May 19, 2013