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

NCT05270343 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 198

Last updated 2022-05-23

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Cholecalciferol (Vit D3) 400Unit Cap

Each subject will take Vit D3 (400Unit Cap) with breakfast for 12 consecutive months, and the initial load will be 140IU/kg qd until the serum 25(OH)D3 is maintained at the upper limit of normal ( 50-80ng/ml\[125-200nmol/L\], ≤100ng/ml\[≤250nmol/L\]), then maintained at 70IU/kg qd, combined with intensive insulin therapy

Sponsors & Collaborators

  • Shanghai Jiao Tong University School of Medicine

    lead OTHER

Principal Investigators

  • Zhiya Dong · Department of Pediatrics, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2023-01-01
Completion
2024-12-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05270343 on ClinicalTrials.gov