Immune and Metabolic Effects of Vitamin D Supplementation in Healthy Humans

NCT ID: NCT01248442

Last Updated: 2012-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2010-06-30

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.

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.

Conditions

Healthy Humans

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Cholecalciferol

Group Type: EXPERIMENTAL

Cholecalciferol

Intervention Type: DRUG

monthly dose of 140.000 IU of cholecalciferol orally, 3 times.

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching Placebo

Interventions

Cholecalciferol

monthly dose of 140.000 IU of cholecalciferol orally, 3 times.

Intervention Type: DRUG

Placebo

Matching Placebo

Intervention Type: DRUG

Other Intervention Names

Oleovit D3; Almondoil

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of Graz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas R Pieber, Prof.

Role: PRINCIPAL_INVESTIGATOR

Medical University of Graz

Locations

Medical University Graz

Graz, , Austria

Countries

Austria

References

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.

Reference Type: DERIVED

PMID: 23999998 (View on PubMed)

Other Identifiers

ENM-EA-011

Identifier Type: -

Identifier Source: org_study_id