Actively Recruiting
Impact of Vitamin D Therapy on Thyroid Function and Antibody Levels in Pediatric Graves' Disease
Led by Northwell Health · Updated on 2026-01-27
30
Participants Needed
1
Research Sites
82 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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...
- New pediatric patients aged 9 to 17 years with a recent diagnosis of Graves' disease
- Started on methimazole treatment
- Biochemical evidence of Graves' disease including suppressed TSH (<0.1), elevated T3, Free T4, and T4
- Positive for TSI or TRAb antibodies
- Non-English speaking participants are eligible
You will not qualify if you...
- Initial hydroxy vitamin D levels greater than 80 ng/mL
- Low corrected calcium levels below 8.4 mg/dL
- High corrected calcium levels above 10.5 mg/dL
- Conditions affecting vitamin D metabolism such as malabsorption, chronic kidney or liver disease, nephrocalcinosis, or hyperparathyroidism
- Current use of medications affecting thyroid function or vitamin D metabolism like 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 of age at diagnosis
- Pregnant participants
- Active or uncontrolled infections or other significant medical conditions that may interfere with participation or increase risk
AI-Screening
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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
CONTACT
S
Sofya Ilmer, MD
CONTACT
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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