Statin and Vitamin D Treatment in Patients With Thyroid Eye Disease

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorTaipei Veterans General Hospital, Taiwan

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Atorvastatin (Lipitor)
  • Vitamin D

Treatment groups

120 Participants
are divided into 4 treatment groups