Statin and Vitamin D Treatment in Patients With Thyroid Eye Disease

Recruiting now · Not applicable

Conditions studied: Thyroid Eye Disease, TED, Graves Ophthalmopathy

In brief

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

Key facts

Study ID

NCT07400757

Run by

Taipei Veterans General Hospital, Taiwan

People needed

120

Starts

2026-02-24

Expected to finish

2032-07-15

Last updated by the study team

2026-04-30

Who can join

Age: 20 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Taipei Veterans General Hospital — Taipei, Taiwan, Taiwan (enrolling)

Full record on ClinicalTrials.gov

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