Impact of Vitamin D Therapy on Thyroid Function and Antibody Levels in Pediatric Graves' Disease (NCT07369063)
Impact of Vitamin D Therapy on Thyroid Function and Antibody Levels in Pediatric Graves' Disease: A Pilot Feasibility Trial
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Pediatric Endocrinology at Northwell Health — New Hyde Park, New York
Age range: 9 Years to 17 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Pediatric Endocrinology at Northwell Health — New Hyde Park, New York
📞 Contact the Study Coordinator
Phone: (516) 472-3750
Email: Shyman1@northwell.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Graves Disease
- Evaluating an AI Tool for Detecting Thyrotoxic States — San Francisco, California
- Study to Determine if BHV-1300 is Effective and Safe in Adults With Graves' Disease — Burbank, California
- Preoperative Corticosteroids in Autoimmune Thyroid Disease — Indianapolis, Indiana
- Study of BHV-1300 in Graves' Disease — South Gate, California
- NEXUS Study: A Study to Test Single and Multiple Doses of MER511 Given to Adults With Graves' Disease — Torrance, California
Explore by condition: All Graves Disease clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.