Early High-Dose Vitamin D and Residual β-Cell Function in Pediatric Type 1 Diabetes

• Status: Not yet recruiting
• Trial end date: 2024-12-30
• Target enrollment: 0
• Participant gender: All

Summary

The project aims to study the effect of early high-dose vitamin D supplementation on type 1 diabetes in children and adolescents receiving intensive insulin therapy. The results may lead to major changes in the early treatment of type 1 diabetes, with special emphasis on the use of vitamin D to improve the function of residual β-cells and maintain standardized insulin therapy for these patients. The overall goal is to reduce the long-term complications of type 1 diabetes.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Jiao Tong University School of Medicine
• Treatments: Cholecalciferol

Criteria

Inclusion Criteria:

1. Age: 3-18 years

2. Sex: male and female participants will be enrolled

3. Immune-mediated T1D: presence of at least one diabetes-associated autoantibody (ADA 2021 guideline for reference)

4. T1D duration of <6 months (from first diagnosis of T1D)

5. Fasting C-peptide level (FCP) of >0.1 nmol/L (0.3ng/mL) ; or 2-hour post-meal stimulated C-peptide level (PCP) of ≥ 0.2 nmol/L(0.6 ng/mL)(with mixed meal tolerance test, MMTT)

6. Vitamin D deficiency: baseline 25(OH)D3< 30 ng/mL (<75 nmol/L)

Exclusion Criteria:

1. Participants with severe chronic and systemic diseases: tumors, immunodeficiency, arteriosclerosis, heart failure, hypercholesterolemia, kidney disease

2. Participants with calcium and phosphorus metabolism disorders

3. Participants on medications or dietary supplements that affect Ca or Vitamin D in the past 6 months

4. Participants on medications other than insulin that can affect blood glucose level

5. Participants with malabsorption

6. Participants with infectious diseases

7. Participants with mental illness

8. The receipt of any investigational drug within 6 months prior to this trial