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

Part of paid clinical trials in New Hyde Park, New York.

Sponsor
Northwell Health
Study ID
NCT07369063
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
9 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Ergocalciferol 50,000 IU — DRUG
    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).
  • Methimazole — DRUG
    Methimazole is considered standard of care for pediatric Graves' disease. Dosing is determined and adjusted by the participant's treating physician

Study Details

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.

Key Dates

Start date
Aug 1, 2025
Status verified
Jan 2026
Primary completion
Feb 28, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: High-Dose Vitamin D2 + Methimazole
    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.
  • Placebo Comparator: Methimazole (with optional low dose Vitamin D2)
    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.

Primary Outcome Measure

Feasibility Metrics: Recruitment Rate [ Time Frame: through study completion, an average of 1 yea ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Pediatric Endocrinology at Northwell HealthNew Hyde ParkNew York11042
Sofya Ilmer, MD
[email protected]
516-472-3750

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Pediatric Endocrinology at Northwell Health· New Hyde Park, NY

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