Impact of Vitamin D Therapy on Thyroid Function and Antibody Levels in Pediatric Graves' Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age9-17
SponsorNorthwell Health
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Suppressed TSH <0.1.
Elevated T3
Elevated Free T4
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Ergocalciferol 50,000 IU
DrugParticipants 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).
Methimazole
DrugMethimazole is considered standard of care for pediatric Graves' disease. Dosing is determined and adjusted by the participant's treating physician
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: High-Dose Vitamin D2 + MethimazoleExperimental treatment 2 interventions
Group B: Methimazole (with optional low dose Vitamin D2)Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility Metrics: Recruitment Rate
Percentage of eligible participants approached who consent to participate in the study. This metric will assess the efficiency of recruitment strategies.
Time frame
through study completion, an average of 1 yea2
Feasibility Metrics: Adherence Rate
Percentage of prescribed vitamin D doses taken by participants in the intervention arm. Adherence will be tracked via pill counts and participant self-report.
Time frame
From enrollment to 24 week/6month follow up visit3
Feasibility Metrics: Data Completeness
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.
Time frame
From baseline data collection to the 24-week/6-month follow-up visit.4
Feasibility Metrics: Implementation Barriers
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.
Time frame
through study completion, an average of 1 yearSecondary outcomes
1
Time to Normalization and Thyroid function Trends
We hypothesize that patients receiving high-dose vitamin D will achieve normal TSH, T3, Free T4 and T4 levels significantly faster than those receiving methimazole alone. Thyroid function tests will be measured at baseline, 6, 12 and 24 weeks, and time to normalization will be compared between groups.
Time frame
from enrollment to 24 week/6month follow up visitOther outcomes
1
Change in TRAb and TSI Levels
We hypothesize that patients receiving high-dose vitamin D will experience a significantly greater percentage reduction in TSH R-Ab and TSI levels at 24 weeks compared to those receiving methimazole alone. Antibody levels will be measured at baseline and 24 weeks, and the percentage change from baseline will be compared between groups.
Time frame
from enrollment to 24 week/6month visitSponsors and contacts
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Source ClinicalTrials.gov