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NCT07369063 · ClinicalTrials.gov registry record · Phase 2
Impact of Vitamin D Therapy on Thyroid Function and Antibody Levels in Pediatric Graves' Disease
A Phase 2 study of Graves Disease and Hyperthyroidism, sponsored by Northwell Health.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT07369063 is a Phase 2 study of Graves Disease and Hyperthyroidism that is actively recruiting participants, run by Northwell Health. The registered enrollment target is 30 participants, below the 307-participant average among 11 other Graves Disease trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state.
The verdict
NCT07369063, a Phase 2 study of Graves Disease and Hyperthyroidism, is actively recruiting participants, sponsored by Northwell Health.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
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 Studied
Interventions
- DRUG Methimazole
- DRUG Ergocalciferol 50,000 IU
Study Locations (1)
New York
- Pediatric Endocrinology at Northwell Health - New Hyde Park
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2025-08-01 |
| Est. Completion | 2027-02-28 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07369063
The ClinicalTrials.gov registry entry for NCT07369063 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 307-participant average among 11 other Graves Disease trials with a reported enrollment target (90% lower). The listed sponsor is Northwell Health, which has 370 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Graves Disease appearing as the primary indexed condition, and to 2 interventions - of which Methimazole is the first listed.
NCT07369063 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT07369063 about?
NCT07369063 is a clinical study titled "Impact of Vitamin D Therapy on Thyroid Function and Antibody Levels in Pediatric Graves' Disease". 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 a...
What is the current status of trial NCT07369063?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2025-08-01. Estimated completion is 2027-02-28.
What conditions does trial NCT07369063 study?
This clinical trial studies the following conditions: Graves Disease, Hyperthyroidism.
What interventions are being tested in trial NCT07369063?
The interventions under investigation include: Methimazole (DRUG), Ergocalciferol 50,000 IU (DRUG).
Who is sponsoring clinical trial NCT07369063?
This trial is sponsored by Northwell Health, which has 370 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07369063 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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