Impact of Vitamin D Therapy on Thyroid Function and Antibody Levels in Pediatric Graves' Disease
Key facts
- Where
- New Hyde Park, United StatesSee the site
- Phase
- Phase 2
Where in United States
- Pediatric Endocrinology at Northwell HealthNew Hyde Park, United StatesNo longer taking part
Trial details
- Who runs it
- Northwell Health
- Trial code
- NCT07369063
- Record updated
- 23 October 2026
- Original description
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:Read full original descriptionShow less
Impact of Vitamin D Therapy on Thyroid Function and Antibody Levels in Pediatric Graves' Disease: A Pilot Feasibility 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.
Inclusion: 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: Current use of medications which are known to affect thyroid function or vitamin D metabolism such as thyroid hormone replacement, corticosteroids, anticonvulsants; Diagnosis of Hashitoxicosis or thyrotoxicosis (both TSH receptor antibody (TRAb) and thyroid-stimulating immunoglobulin (TSI) levels are negative); Conditions that affect vitamin D metabolism such as: malabsorption, chronic kidney or liver disease, nephrocalcinosis, hyperparathyroidism; Allergy to vitamin D or methimazole; Active or uncontrolled infections, other significant medical conditions deemed by the investigator to interfere with study participation or pose undue risk to the participant; Hypocalcemia, corrected calcium based on albumin <8.4 mg/dL; Hypercalcemia, corrected calcium based on albumin >10.5 mg/dL; Participants under the age of 9 years at the time of diagnosis; Initial hydroxy vitamin D levels >80 ng/mL; Pregnant participants.