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.
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Nov 2009
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
November 24, 2010
CompletedFirst Posted
Study publicly available on registry
November 25, 2010
CompletedFebruary 9, 2012
February 1, 2012
7 months
November 24, 2010
February 8, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (4)
immunophenotyping
3 months
Renin and aldosterone concentrations
3 months
Insulin secretion
3 months
calcium levels
3 months
Study Arms (2)
Cholecalciferol
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
monthly dose of 140.000 IU of cholecalciferol orally, 3 times.
Eligibility Criteria
You may qualify if:
- Age \>= 10 years
- healthy subjects without chronic disease
You may not qualify if:
- Hypercalcemia \>2,65 mmol/L
- pregnancy and lactation period
- acute infections
- chronic disease requiring treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University Graz
Graz, 8036, Austria
Related Publications (1)
Prietl B, Treiber G, Mader JK, Hoeller E, Wolf M, Pilz S, Graninger WB, Obermayer-Pietsch BM, Pieber TR. High-dose cholecalciferol supplementation significantly increases peripheral CD4(+) Tregs in healthy adults without negatively affecting the frequency of other immune cells. Eur J Nutr. 2014 Apr;53(3):751-9. doi: 10.1007/s00394-013-0579-6. Epub 2013 Sep 3.
PMID: 23999998DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas R Pieber, Prof.
Medical University of Graz
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 24, 2010
First Posted
November 25, 2010
Study Start
November 1, 2009
Primary Completion
June 1, 2010
Study Completion
June 1, 2010
Last Updated
February 9, 2012
Record last verified: 2012-02