Effects of Vitamin D Supplementation in Subjects With New Onset of Type 1 Diabetes

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Drug: Cholecalciferol


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>peanut oil | Drug: Cholecalciferol<br>* weekly dose (based on 70 IU/kg bodyweight/day) orally<br>* Other names: Placebo: peanut oil;|
| Active Comparator: Vitamin D (Oleovit®)<br>cholecalciferol | Drug: Cholecalciferol<br>* weekly dose (based on 70 IU/kg bodyweight/day) orally<br>* Other names: Placebo: peanut oil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase and function of regulatory T-cells | The level and function of the regulatory T-cells will be compared between the two groups. | 13 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunophenotyping | The effect of vitamin D on circulating immune cells and cytokine secretion at basal, after 3, 6 and 12 months. | 13 months | 
| Insulin secretion | Insulin secretion assessed with a mixed meal tolerance test will be performed basal, after 3, 6 and 12 months. | 13 months | 
| Calcium levels | Serum calcium levels will be measured basal, after 1,3,6,9 and 12 months. | 13 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vitamin D, Autoimmune disease, diabetes