Clinical Trial

Statin and Vitamin D Treatment in Patients With Thyroid Eye Disease

Recruiting
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Summary
The goal of this clinical trial is to learn whether statin therapy and vitamin D supplementation can modify disease activity in patients with active thyroid eye disease. The study will also evaluate the safety of these treatments. The main questions it aims to answer are: * Does statin therapy change disease activity, as measured by changes in the Clinical Activity Score (CAS) and proptosis? * Does vitamin D supplementation change disease activity in patients with active thyroid eye disease? * Does combined treatment with statin and vitamin D produce different effects compared with either treatment alone or standard care? * What adverse events occur during treatment? Researchers will compare four groups: standard care alone, statin therapy plus standard care, vitamin D supplementation plus standard care, and combined statin and vitamin D therapy plus standard care. Participants will: * Be randomly assigned to one of four treatment groups * Receive the assigned treatment for 24 weeks * Attend clinic visits for clinical assessments and blood tests at baseline and at 24 weeks * Be followed through medical record review for up to three years after completion of the intervention
Protocol Amendment History 1 change
critical Recruitment opened 2026-05-01
Trial Details
NCT Number NCT07400757
Lead Sponsor Taipei Veterans General Hospital, Taiwan
Conditions Thyroid Eye Disease, TED, Graves Ophthalmopathy
Enrollment 120 participants
Start Date 2026-02-24
Primary Completion 2029-12-31 (estimated)
Study Completion 2032-07-15 (estimated)
Updated on ClinicalTrials.gov 2026-04-30