NCT07369063 Impact of Vitamin D Therapy on Thyroid Function and Antibody Levels in Pediatric Graves' Disease
| NCT ID | NCT07369063 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Northwell Health |
| Condition | Graves Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-08-01 |
| Primary Completion | 2027-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2025-08-01 with a primary completion date of 2027-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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 are known to affect thyroid function or vitamin D metabolism such as thyroid hormone replacement, corticosteroids, anticonvulsants * Allergy to vitamin D or methimazole * Diagnosis of Hashitoxicosis or thyrotoxicosis (both TSH receptor antibody (TRAb) and thyroid-stimulating immunoglobulin (TSI) levels are negative) * Participants under the age of 9 years at the time of diagnosis * Pregnant participants * Active or uncontrolled infections, other significant medical conditions deemed by the investigator to interfere with study participation or pose undue risk to the participant.
Contact & Investigator
Sharon Hyman, MD
PRINCIPAL INVESTIGATOR
Northwell Health
Frequently Asked Questions
Who can join the NCT07369063 clinical trial?
This trial is open to participants of all sexes, aged 9 Years or older, up to 17 Years, studying Graves Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07369063 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07369063 currently recruiting?
Yes, NCT07369063 is actively recruiting participants. Contact the research team at Shyman1@northwell.edu for enrollment information.
Where is the NCT07369063 trial being conducted?
This trial is being conducted at New Hyde Park, United States.
Who is sponsoring the NCT07369063 clinical trial?
NCT07369063 is sponsored by Northwell Health. The principal investigator is Sharon Hyman, MD at Northwell Health. The trial plans to enroll 30 participants.