NCT07400757 Statin and Vitamin D Treatment in Patients With Thyroid Eye Disease

Trial Parameters

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Brief 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

Eligibility Criteria

Inclusion Criteria: * Adults aged 20 years or older * Diagnosis of active thyroid eye disease with a Clinical Activity Score (CAS) of 3 or higher * Low-density lipoprotein cholesterol (LDL-C) level of 100 mg/dL or higher Exclusion Criteria: * Prior orbital radiotherapy or orbital surgery for thyroid eye disease * Use of statins or high-dose vitamin D supplementation (greater than 400 IU per day) within 3 months prior to enrollment * Pregnancy * Severe renal impairment, defined as an estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73 m²

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