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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014