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| Name | Class |
|---|---|
| Medical University of Vienna | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | peanut oil |
|
| Vitamin D (Oleovit®) | Active Comparator | cholecalciferol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cholecalciferol | Drug | weekly dose (based on 70 IU/kg bodyweight/day) orally |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Pieber, Prof. | Medical University of Graz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University Graz | Graz | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26277548 | Derived | Treiber G, Prietl B, Frohlich-Reiterer E, Lechner E, Ribitsch A, Fritsch M, Rami-Merhar B, Steigleder-Schweiger C, Graninger W, Borkenstein M, Pieber TR. Cholecalciferol supplementation improves suppressive capacity of regulatory T-cells in young patients with new-onset type 1 diabetes mellitus - A randomized clinical trial. Clin Immunol. 2015 Dec;161(2):217-24. doi: 10.1016/j.clim.2015.08.002. Epub 2015 Aug 12. |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D001327 | Autoimmune Diseases |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| 13 months |
| Calcium levels | Serum calcium levels will be measured basal, after 1,3,6,9 and 12 months. | 13 months |
| D007154 | Immune System Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |