NCT07369063 · Northwell Health
Impact of Vitamin D Therapy on Thyroid Function and Antibody Levels in Pediatric Graves' Disease
What this study is about
The goal of this randomly assigned 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.
View original scientific 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: 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.
Interventions
DRUG
Ergocalciferol 50,000 IU
Participants will receive ergocalciferol 50,000 IU oral capsules weekly for the first 8 weeks, followed by 50,000 IU every two weeks for the subsequent 16 weeks (total 24 weeks).
DRUG
Methimazole
Methimazole is considered standard of care for pediatric Graves' disease. Dosing is determined and adjusted by the participant's treating physician
Primary outcome measures
Feasibility Metrics: Recruitment Rate
Time frame: through 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 Rate
Time frame: From 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 Completeness
Time frame: From 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 Barriers
Time frame: through 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- New Hyde Park, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 27, 2026 · Source of record for eligibility and locations