Pilot Study on High-Dose Vitamin D and Methimazole Effects on Thyroid Function in Children with Graves Disease

What this Trial Is About

Researchers are evaluating the feasibility of a larger clinical trial to study the effects of high-dose vitamin D supplementation in children aged 9 to 17 years newly diagnosed with Graves disease. The study aims to explore recruitment and adherence rates, data collection quality, and potential barriers to a larger trial. It will also assess how vitamin D combined with standard methimazole therapy might affect thyroid hormone and antibody levels in this pediatric group. Participants will be randomly assigned to one of two groups one receiving methimazole plus high-dose vitamin D2, and the other receiving methimazole alone with the option to take up to 1000 IU of vitamin D2 daily over-the-counter. The intervention group will take 50,000 IU of vitamin D2 weekly for eight weeks, then every two weeks for sixteen weeks, alongside methimazole treatment. The control group will follow standard methimazole therapy, with optional low-dose vitamin D2. During the 24-week study period, participants will attend regular visits for blood tests and clinical assessments, including tracking thyroid hormone levels and antibody changes. Researchers will monitor adherence through pill counts and medication logs, assess recruitment and data completeness, and watch for safety concerns like calcium imbalances. The study will provide important data to guide a future, larger trial evaluating vitamin Ds role in pediatric Graves disease treatment.

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