Clinical Trial Details
| Trial ID: | L2519 |
| Source ID: | NCT01390480 |
| Associated Drug: | Cholecalciferol |
| Title: | Effects of Vitamin D Supplementation in Subjects With New Onset of Type 1 Diabetes |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Type 1 Diabetes |
| Interventions: | DRUG: Cholecalciferol |
| Outcome Measures: | Primary: 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: 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 |
| Sponsor/Collaborators: | Sponsor: Medical University of Graz | Collaborators: Medical University of Vienna |
| Gender: | ALL |
| Age: | CHILD, ADULT |
| Phases: | PHASE4 |
| Enrollment: | 31 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: PREVENTION |
| Start Date: | 2010-11 |
| Completion Date: | 2014-02 |
| Results First Posted: | |
| Last Update Posted: | 2015-04-17 |
| Locations: | Medical University Graz, Graz, Austria |
| URL: | https://clinicaltrials.gov/show/NCT01390480 |
