Placebo Controlled Pilot Study on Effects of Vitamin D Supplementation in Subjects With New Onset of Type 1 Diabetes on Immunological, Endocrine and Metabolic Parameters: Step 2 in the Austrian Diabetes Prevention Programme
Overview
- Phase
- Phase 4
- Intervention
- Cholecalciferol
- Conditions
- Type 1 Diabetes
- Sponsor
- Medical University of Graz
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- Increase and function of regulatory T-cells
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •males or females \> 6 years
- •new onset of type 1 diabetes (3 months)
Exclusion Criteria
- •pregnancy
- •hypercalcemia (\>2,65 mmol/L)
- •chronic disease including a long-term medication over 4 weeks per year (except type 1 diabetes)
Arms & Interventions
Placebo
peanut oil
Intervention: Cholecalciferol
Vitamin D (Oleovit®)
cholecalciferol
Intervention: Cholecalciferol
Outcomes
Primary Outcomes
Increase and function of regulatory T-cells
Time Frame: 13 months
The level and function of the regulatory T-cells will be compared between the two groups.
Secondary Outcomes
- Calcium levels(13 months)
- Immunophenotyping(13 months)
- Insulin secretion(13 months)