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The Role of Statin and Vitamin D for the Treatment of Thyroid Eye Disease

Status: Recruiting
Location: See location...
Intervention Type: Drug, Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 20
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Taiwan
Taipei Veterans General Hospital
RECRUITING
Taipei
Contact Information
Primary
Chin-Sung Kuo, MD, PhD
cskuo@vghtpe.gov.tw
886-2-28757513
Time Frame
Start Date: 2026-02-24
Estimated Completion Date: 2032-07-15
Participants
Target number of participants: 120
Treatments
No_intervention: Standard Care
Participants receive standard care for active thyroid eye disease according to current clinical practice for 24 weeks.
Experimental: Statin
Participants receive standard care plus oral atorvastatin 20 mg once daily for 24 weeks.
Experimental: Vitamin D
Participants receive standard care plus oral vitamin D supplementation at a dose of 1400 IU daily for 24 weeks.
Experimental: Statin plus Vitamin D
Participants receive standard care plus oral atorvastatin 20 mg once daily and oral vitamin D supplementation at a dose of 1400 IU daily for 24 weeks.
Sponsors
Leads: Taipei Veterans General Hospital, Taiwan

This content was sourced from clinicaltrials.gov