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

NCT05270343 | Unknown Phase 3

• 1 other identifier: YZhang
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

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 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

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Glycemic control (HbA1c)

  12 months

• Glycemic control (free blood glucose)

  12 months

• Glycemic control (postprandial blood glucose)

  12 months

• Islet Function (stimulated C-peptide)

  12 months

• Daily Insulin Dosage

  12 months

Study Arms (2)

Vitamin D

EXPERIMENTAL

In 99 subjects of 3-18yr with newly-onset T1D, oral administration of 140IU/kg qd of cholecalciferol will be given until the serum 25(OH)D3 was maintained at the upper limit of normal range(50-80 ng/ml\[125-200 nmol/L\], ≤100 ng/ml\[≤250 nmol/L\]) for the loading peroid. And then oral administration of 70IU/kg qd of cholecalciferol for the maintenance period, meanwhile combined with intensive Insulin therapy for 12 months.

Drug: Cholecalciferol (Vit D3) 400Unit Cap

Insulin

NO INTERVENTION

In 99 subjects of 3-18yr with newly-onset T1D, only intensive insulin therapy will be given for 12 months.

Interventions

Cholecalciferol (Vit D3) 400Unit Cap DRUG

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

Also known as: Cholecalciferol

Vitamin D

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Department of Pediatrics, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, 200025, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Zhiya Dong

  Department of Pediatrics, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhiya Dong

CONTACT

64370045; dzy831@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The Effect of Early High-dose Vitamin D Intervention on the Residual β-cell Function in Adolescents and Children With Type 1 Diabetes

Study Record Dates

• First Submitted: February 25, 2022
• First Posted: March 8, 2022
• Study Start: June 1, 2022
• Primary Completion: January 1, 2023
• Study Completion: December 30, 2024
• Last Updated: May 23, 2022

Record last verified: 2022-05

Locations

CN (1)