| Trial ID: | L4938 |
| Source ID: | NCT05270343
|
| Associated Drug: |
Cholecalciferol (Vit D3) 400unit Cap
|
| Title: |
Early High-Dose Vitamin D and Residual β-Cell Function in Pediatric Type 1 Diabetes
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 1 Diabetes
|
| Interventions: |
DRUG: Cholecalciferol (Vit D3) 400Unit Cap
|
| Outcome Measures: |
Primary: Residual β-Cell function (RBCF), To study the effect of early supplementation of high-dose vitamin D on RBCF in the first 12 months after diagnosis of T1D by using fasting C-peptide(FCP) levels to quantify RBCF across longitudinal measurements, 12 months | Secondary: Glycemic control (HbA1c), To study the effect of early supplementation of high-dose vitamin D on glycemic control by comparing HbA1c values across longitudinal measurements, 12 months|Glycemic control (free blood glucose), To study the effect of early supplementation of high-dose vitamin D on glycemic control by comparing free blood glucose (FBG) values across longitudinal measurements, 12 months|Glycemic control (postprandial blood glucose), To study the effect of early supplementation of high-dose vitamin D on glycemic control by comparing postprandial blood glucose (PBG) values across longitudinal measurements, 12 months|Islet Function (stimulated C-peptide), To study the effect of early supplementation of high-dose vitamin D on the reserve capacity of RBCF by using 2-hour post-meal stimulated C peptide (PCP) with mixed meal tolerance test (MMTT) across longitudinal measurements, 12 months|Daily Insulin Dosage, To study the effect of early supplementation of high-dose vitamin D on the insulin requirement by using daily insulin dosage per body weight (DID IU/kg.d) across longitudinal measurements, 12 months
|
| Sponsor/Collaborators: |
Sponsor: Shanghai Jiao Tong University School of Medicine
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
198
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2022-06-01
|
| Completion Date: |
2024-12-30
|
| Results First Posted: |
|
| Last Update Posted: |
2022-05-23
|
| Locations: |
Department of Pediatrics, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200025, China
|
| URL: |
https://clinicaltrials.gov/show/NCT05270343
|
