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Immune and Metabolic Effects of Vitamin D Supplementation in Healthy Humans

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ClinicalTrials.gov Identifier: NCT01248442
Recruitment Status : Completed
First Posted : November 25, 2010
Last Update Posted : February 9, 2012
Sponsor:
Information provided by (Responsible Party):
Medical University of Graz

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Humans Drug: Cholecalciferol Drug: Placebo Phase 4

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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.
Study Start Date : November 2009
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Renin and aldosterone concentrations [ Time Frame: 3 months ]
    serum renin and aldosterone levels will be measured basal and after 3 months.

  3. Insulin secretion [ Time Frame: 3 months ]
    Insulin secretion assessed with a mixed meal tolerance test will be performed basal and after 3 months

  4. calcium levels [ Time Frame: 3 months ]
    serum calcium levels will be measured basal and monthly for 3 months.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT01248442     History of Changes
Other Study ID Numbers: ENM-EA-011
First Posted: November 25, 2010    Key Record Dates
Last Update Posted: February 9, 2012
Last Verified: February 2012

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

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