Actively Recruiting

Phase Not Applicable
Age: 20Years +
All Genders
NCT07400757

Statin and Vitamin D Treatment in Patients With Thyroid Eye Disease

Led by Taipei Veterans General Hospital, Taiwan · Updated on 2026-04-30

120

Participants Needed

1

Research Sites

333 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Statin and Vitamin D Treatment in Patients With Thyroid Eye Disease

Who Can Participate

Age: 20Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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 m�b2

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Taipei Veterans General Hospital

Taipei, Taiwan, Taiwan, 11217

Actively Recruiting

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Research Team

C

Chin-Sung Kuo, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

FACTORIAL

Primary Purpose

TREATMENT

Number of Arms

4

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