Impact of Vitamin D Therapy on Thyroid Function and Antibody Levels in Pediatric Graves' D
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: W
| Condition(s) | Graves Disease, Graves' Disease, Hyperthyroidism |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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 hormo |
| Who can participate | 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 based on albumin \>10.5 mg/dL * Conditions that affect vitamin D metabolism such as: malabsorption, chronic kidney or liver disease, nephrocalcinosis, hyperparathyroidism * Current use of medications which a |
| Ages | 9 Years to 17 Years |
| Sex | All |
| Lead sponsor | Northwell Health |
| Locations | New Hyde Park, New York, United States |
| Start date | 2025-08-01 |
| NCT ID | NCT07369063 |
| Official listing | https://clinicaltrials.gov/study/NCT07369063 |