| Trial ID: | L2042 |
| Source ID: | NCT03046927
|
| Associated Drug: |
Ergocalciferol
|
| Title: |
Vitamin D and Residual Beta-Cell Function in Type 1 Diabetes
|
| Acronym: |
PCR
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT03046927/results
|
| Conditions: |
Type 1 Diabetes
|
| Interventions: |
DRUG: Ergocalciferol|OTHER: Placebo
|
| Outcome Measures: |
Primary: Residual Beta-cell Function (RBCF), Investigation of the effect of vitamin D on residual beta cell function (RBCF) in the first 12 months after the diagnosis of T1D by using stimulated C-peptide levels to quantify RBCF., Baseline to 12 months at 3 months interval | Secondary: Change in Percent of HbA1c From Baseline Over Time During Partial Clinical Remission (PCR), Effect of vitamin D supplementation on glycemic control during the partial clinical remission phase as shown by the change in percent HbA1c from baseline across longitudinal measurements at 0, 3, 6, 9, and 12 months., Baseline to 12 months|Glucagon-like Peptide-1 (GLP-1), Investigation of the effect of vitamin D supplementation on GLP-1 during PCR., Baseline to 12 months at 3 months interval|Vitamin D Binding Protein (VDBP), Investigation of the effect of vitamin D supplementation on VDBP during PCR., Baseline to 12 months at 3 months interval|Effect of Vitamin D Supplementation on the Duration of Partial Clinical Remission (PCR) of Type 1 Diabetes, Insulin dose-adjusted hemoglobin A1c (HbA1c) (IDAA1C), Baseline to12 months 3 monthly
|
| Sponsor/Collaborators: |
Sponsor: Benjamin U. Nwosu, MD | Collaborators: University of Massachusetts, Worcester|National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT
|
| Phases: |
PHASE2|PHASE3
|
| Enrollment: |
48
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2017-10-19
|
| Completion Date: |
2021-04-20
|
| Results First Posted: |
2024-07-10
|
| Last Update Posted: |
2024-07-10
|
| Locations: |
University of Massachusetts Medical School, Worcester, Massachusetts, 01655, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT03046927
|
