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RECRUITING
NCT07369063
PHASE2

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

Sponsor: Northwell Health

View on ClinicalTrials.gov

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.

Official title: Impact of Vitamin D Therapy on Thyroid Function and Antibody Levels in Pediatric Graves' Disease: A Pilot Feasibility Trial

Key Details

Gender

All

Age Range

9 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2025-08-01

Completion Date

2027-02-28

Last Updated

2026-01-27

Healthy Volunteers

No

Interventions

DRUG

Ergocalciferol 50,000 IU

Participants will receive ergocalciferol 50,000 IU oral capsules weekly for the first 8 weeks, followed by 50,000 IU every two weeks for the subsequent 16 weeks (total 24 weeks).

DRUG

Methimazole

Methimazole is considered standard of care for pediatric Graves' disease. Dosing is determined and adjusted by the participant's treating physician

Locations (1)

Pediatric Endocrinology at Northwell Health

New Hyde Park, New York, United States