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Vitamin D and Thyroid Function in Pediatric Graves' Disease

This study is looking at whether adding high-dose vitamin D (ergocalciferol) to standard treatment helps children with Graves' disease (an autoimmune condition causing an overactive thyroid). You could be eligible if you are 9-17 years old, have a new diagnosis of Graves' disease, and meet specific blood test requirements showing an overactive thyroid and positive antibodies (TSI or TRAb). Participants will receive either ergocalciferol plus methimazole (the usual treatment) or methimazole alone. The main goal of this study is to see how easy it is to recruit participants, how well they stick to the treatment plan, and if the data collected is complete enough for a larger study in the future. The current recruitment status is unclear.

Study design
This is a pilot feasibility study aiming to enroll 30 participants. It compares ergocalciferol plus methimazole to methimazole alone.
What's involved
Participants will take ergocalciferol capsules weekly for 8 weeks, then every two weeks for 16 weeks (total 24 weeks). Methimazole dosing will be determined by your doctor.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 24 weeks (6 months) after enrollment.

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NCT07369063

Impact of Vitamin D Therapy on Thyroid Function and Antibody Levels in Pediatric Graves' Disease

Recruiting
PHASE2Ages 9–17Interventional
Northwell Health
~30 participants
Updated 2026-01-27 on ClinicalTrials.gov
What's tested:Ergocalciferol 50,000 IUMethimazole

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility Metrics: Recruitment Rate
Measured over through study completion, an average of 1 yea
+3 more outcomes measured

Conditions

Graves Disease
Graves' Disease
Hyperthyroidism

Explore related trials

Graves DiseaseTSI or TRAb

NCT07369063

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Pediatric Endocrinology at Northwell Health

    New Hyde Park, New Yorkstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Sharon Hyman, MD · PRINCIPAL_INVESTIGATOR · Northwell Health

Who to contact

Sharon Hyman, MD
[email protected]
15164723750
Email the study team

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Eligibility criteria

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

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.

What this trial measures

  • Feasibility Metrics: Recruitment Ratethrough study completion, an average of 1 yea

    Percentage of eligible participants approached who consent to participate in the study. This metric will assess the efficiency of recruitment strategies.

  • Feasibility Metrics: Adherence RateFrom enrollment to 24 week/6month follow up visit

    Percentage of prescribed vitamin D doses taken by participants in the intervention arm. Adherence will be tracked via pill counts and participant self-report.

  • Feasibility Metrics: Data CompletenessFrom baseline data collection to the 24-week/6-month follow-up visit.

    Percentage of completed data fields for key outcome measures (thyroid function tests, TSI levels, etc.). This will assess the quality and completeness of data collection.

  • Feasibility Metrics: Implementation Barriersthrough study completion, an average of 1 year

    A qualitative assessment of any challenges encountered during the study implementation (e.g., recruitment difficulties, adherence issues, logistical problems). This assessment will inform strategies for overcoming these barriers in a future, larger-scale RCT.