Vitamin D for Graves' Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
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 Is on the Research Team?
Sharon Hyman, MD
Principal Investigator
Northwell Health
Are You a Good Fit for This Trial?
This trial is for children aged 9-17 who have recently been diagnosed with Graves' disease. They must be able to take vitamin D and methimazole, attend regular study visits, and keep a medication log. Specific criteria for joining or reasons why someone can't participate are not provided.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive methimazole and high-dose vitamin D2 (50,000 IU weekly for 8 weeks, then every two weeks for 16 weeks) or methimazole with optional low-dose vitamin D2
Follow-up
Participants are monitored for safety and effectiveness after treatment, including thyroid function tests and antibody levels
What Are the Treatments Tested in This Trial?
Interventions
- Ergocalciferol
Trial Overview
The study tests if high-dose vitamin D (50,000 IU) alongside standard methimazole treatment affects thyroid function and antibody levels differently than just methimazole alone in kids with Graves' disease. It's also checking how feasible it would be to do a larger trial on this.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants in this arm will receive methimazole at a dose determined by their treating physician, according to standard clinical practice guidelines for pediatric Graves' disease. In addition, they will receive high-dose vitamin D2 (ergocalciferol) 50,000 IU orally weekly for the first 8 weeks, followed by 50,000 IU orally every two weeks for the remaining 16 weeks of the study.
Participants in this arm will receive methimazole at a dose determined by their treating physician, according to standard clinical practice guidelines for pediatric Graves' disease. Participants will have the option of taking up to 1000 IU of vitamin D2 daily, purchased over-the-counter, but this will not be provided by the study. This is to address potential vitamin D deficiency while maintaining a comparison group.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Northwell Health
Lead Sponsor
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