Status:
UNKNOWN
Early High-Dose Vitamin D and Residual β-Cell Function in Pediatric Type 1 Diabetes
Lead Sponsor:
Shanghai Jiao Tong University School of Medicine
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
3-18 years
Phase:
PHASE3
Brief 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 chan...
Detailed Description
Type 1 diabetes (T1D) is a chronic autoimmune disease that is immune-mediated destruction of pancreatic β-cells. It relies on insulin therapy. The currently accepted standardized treatment is intensiv...
Eligibility Criteria
Inclusion
- Age: 3-18 years
- Sex: male and female participants will be enrolled
- Immune-mediated T1D: presence of at least one diabetes-associated autoantibody (ADA 2021 guideline for reference)
- T1D duration of \<6 months (from first diagnosis of T1D)
- 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)
- Vitamin D deficiency: baseline 25(OH)D3\< 30 ng/mL (\<75 nmol/L)
Exclusion
- Participants with severe chronic and systemic diseases: tumors, immunodeficiency, arteriosclerosis, heart failure, hypercholesterolemia, kidney disease
- Participants with calcium and phosphorus metabolism disorders
- Participants on medications or dietary supplements that affect Ca or Vitamin D in the past 6 months
- Participants on medications other than insulin that can affect blood glucose level
- Participants with malabsorption
- Participants with infectious diseases
- Participants with mental illness
- The receipt of any investigational drug within 6 months prior to this trial
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2024
Estimated Enrollment :
198 Patients enrolled
Trial Details
Trial ID
NCT05270343
Start Date
June 1 2022
End Date
December 30 2024
Last Update
May 23 2022
Active Locations (1)
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1
Department of Pediatrics, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China, 200025