In this placebo controlled study the investigators aim to investigate the effects of vitamin D supplementation in subjects with new onset of type 1 diabetes on immunological, endocrine and metabolic parameters.
This is a bicentric, randomized placebo controlled, double blind study, with the aim to evaluate the effect of vitamin D supplementation in subjects with new onset of type 1 diabetes on immunological, endocrine and metabolic parameters. The primary study goal is to evaluate the influence of vitamin D supplementation on the number and function of the master regulatory T-cells under controlled conditions within 13 months. The secondary study goals are a comprehensive immune phenotyping to determine whether Vit D produces changes consistent with a general improvement in immune homeostasis that supports ß-cell tolerating interventions, the assessment of ß-cell function in all subjects to obtain preliminary data on the effects of Vit D on ß-cell survival.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
31
weekly dose (based on 70 IU/kg bodyweight/day) orally
Medical University Graz
Graz, Austria
Increase and function of regulatory T-cells
The level and function of the regulatory T-cells will be compared between the two groups.
Time frame: 13 months
Immunophenotyping
The effect of vitamin D on circulating immune cells and cytokine secretion at basal, after 3, 6 and 12 months.
Time frame: 13 months
Insulin secretion
Insulin secretion assessed with a mixed meal tolerance test will be performed basal, after 3, 6 and 12 months.
Time frame: 13 months
Calcium levels
Serum calcium levels will be measured basal, after 1,3,6,9 and 12 months.
Time frame: 13 months
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