Actively Recruiting
Impact of Vitamin D Therapy on Thyroid Function and Antibody Levels in Pediatric Graves' Disease: A Pilot Feasibility Trial
Led by Northwell Health · Updated on 2026-01-27
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the feasibility of a larger clinical trial to study the effects of high-dose vitamin D supplementation in children aged 9 to 17 years newly diagnosed with Graves' disease. The study aims to explore recruitment and adherence rates, data collection quality, and potential barriers to a larger trial. It will also assess how vitamin D combined with standard methimazole therapy might affect thyroid hormone and antibody levels in this pediatric group. Participants will be randomly assigned to one of two groups: one receiving methimazole plus high-dose vitamin D2, and the other receiving methimazole alone with the option to take up to 1000 IU of vitamin D2 daily over-the-counter. The intervention group will take 50,000 IU of vitamin D2 weekly for eight weeks, then every two weeks for sixteen weeks, alongside methimazole treatment. The control group will follow standard methimazole therapy, with optional low-dose vitamin D2. During the 24-week study period, participants will attend regular visits for blood tests and clinical assessments, including tracking thyroid hormone levels and antibody changes. Researchers will monitor adherence through pill counts and medication logs, assess recruitment and data completeness, and watch for safety concerns like calcium imbalances. The study will provide important data to guide a future, larger trial evaluating vitamin D's role in pediatric Graves' disease treatment.
CONDITIONS
Brief Title
Impact of Vitamin D Therapy on Thyroid Function and Antibody Levels in Pediatric Graves' Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 9 to 17 years with a new diagnosis of Graves' disease
- Will be started on methimazole treatment
- Biochemical evidence including suppressed TSH below 0.1, elevated T3, Free T4, and T4
- Positive for Thyroid Stimulating Immunoglobulin (TSI) or Thyroid Receptor Antibody (TRAb)
- Non-English speaking participants are eligible
You will not qualify if you...
- Initial vitamin D levels greater than 80 ng/mL
- Low corrected calcium below 8.4 mg/dL or high corrected calcium above 10.5 mg/dL
- Conditions affecting vitamin D metabolism such as malabsorption, kidney or liver disease, nephrocalcinosis, or hyperparathyroidism
- Current use of medications affecting thyroid function or vitamin D metabolism including thyroid hormone replacement, corticosteroids, or anticonvulsants
- Allergy to vitamin D or methimazole
- Diagnosis of Hashitoxicosis or thyrotoxicosis with negative TRAb and TSI antibodies
- Participants under 9 years old at diagnosis
- Pregnancy
- Active or uncontrolled infections or other serious medical conditions that may interfere with participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants receive methimazole treatment as prescribed by their physician. Those in the experimental arm also receive high-dose vitamin D2 supplementation weekly for 8 weeks, then every two weeks for 16 weeks.
Regular visits as directed by treating physician
Duration - Up to 24 weeks including treatment period
Participants are monitored for thyroid function normalization, antibody level changes, safety, and adherence after treatment completion.
1 follow-up visit at 24 weeks
Trial Site Locations
Total: 1 location
1
Pediatric Endocrinology at Northwell Health
New Hyde Park, New York, United States, 11042
Actively Recruiting
Research Team
S
Sharon Hyman, MD
S
Sofya Ilmer, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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