Clinical Trial

Impact of Vitamin D Therapy on Thyroid Function and Antibody Levels in Pediatric Graves' Disease

Recruiting Phase 2
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Summary
The goal of this randomized pilot feasibility clinical trial is to determine the feasibility of implementing a protocol for a larger trial to assess the effects of high-dose vitamin D supplementation in pediatric patients (9-17 years old) newly diagnosed with Graves' disease. The main questions it aims to answer are: What are the recruitment and adherence rates for a larger trial using this protocol? Is the data collection process complete and robust enough for a larger trial? What are the potential barriers to implementing a larger-scale trial? Researchers will compare vitamin D supplementation plus standard methimazole therapy to methimazole therapy alone (with participants permitted to take up to 1000 International Units of vitamin D2 daily) to explore potential effects on thyroid hormone and antibody levels. Participants will: Be randomized to either the intervention or control group. Take study medications (vitamin D or placebo) as directed. Attend regular study visits for blood tests and clinical assessments. Complete medication logs.
Trial Details
NCT Number NCT07369063
Lead Sponsor Northwell Health
Conditions Graves Disease, Graves' Disease, Hyperthyroidism
Enrollment 30 participants
Start Date 2025-08-01
Primary Completion 2027-02-28 (estimated)
Study Completion 2027-02-28 (estimated)
Updated on ClinicalTrials.gov 2026-01-27