Impact of Vitamin D Therapy on Thyroid Function and Antibody Levels in Pediatric Graves' Disease: A Pilot Feasibility Trial
Northwell Health
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.
Description
This pilot feasibility study will evaluate the practicality of conducting a larger randomized controlled trial (RCT) investigating the impact of high-dose vitamin D2 (ergocalciferol) supplementation as an adjunctive therapy to standard methimazole treatment in pediatric patients aged 9-17 years newly diagnosed with Graves' disease (GD). This study aims to address the current gap in research regarding vitamin D supplementation's effect on antibody and thyroid hormone trends in this population. Specifically, the study will examine the feasibility of recruitment, adherence to the intervention reg…
Eligibility
- Age range
- 9–17 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * All new pediatric participants aged 9-17 years with a new diagnosis of GD who will be started on methimazole, will be offered to participate at the time of diagnosis. * Biochemical features include: * Suppressed TSH \<0.1. * Elevated T3 * Elevated Free T4 * Elevated T4 * Positive TSI or TRAb. The presence of antibodies is diagnostic. * Our study will offer enrollment to non-English speaking participants Exclusion Criteria: * Initial hydroxy vitamin D levels \>80 ng/mL * Hypocalcemia, corrected calcium based on albumin \<8.4 mg/dL * Hypercalcemia, corrected calcium base…
Interventions
- DrugErgocalciferol 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).
- DrugMethimazole
Methimazole is considered standard of care for pediatric Graves' disease. Dosing is determined and adjusted by the participant's treating physician
Location
- Pediatric Endocrinology at Northwell HealthNew Hyde Park, New York