Healthy Humans
Conditions
Keywords
Vitamin D Deficiency, Autoimmune disease, Diabetes
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.
Interventions
DRUGCholecalciferol
monthly dose of 140.000 IU of cholecalciferol orally, 3 times.
DRUGPlacebo
Matching Placebo
Sponsors
Medical University of Graz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Increase and function of peripheral regulatory T-cells | 3 months | The level and function of the regulatory T-cells will be compared between the two groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| immunophenotyping | 3 months | 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 | 3 months | serum renin and aldosterone levels will be measured basal and after 3 months. |
| Insulin secretion | 3 months | Insulin secretion assessed with a mixed meal tolerance test will be performed basal and after 3 months |
| calcium levels | 3 months | serum calcium levels will be measured basal and monthly for 3 months. |
Countries
Austria
Outcome results
None listed