Immune and Metabolic Effects of Vitamin D Supplementation in Healthy Humans

Medical University of Graz

Status and phase: Completed; Phase 4

Conditions: Healthy Humans

Treatments: Drug: Cholecalciferol; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01248442

ENM-EA-011

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Cholecalciferol

Experimental group

Treatment:

Drug: Cholecalciferol

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo