Statin and Vitamin D Treatment in Patients With Thyroid Eye Disease
Key facts
- Who runs it
- Taipei Veterans General Hospital, Taiwan
- Where
- Taipei, TaiwanSee the site
- Trial code
- Status
- Recruiting
- People taking part
- 120 people, planned
- Started
- 24 Feb 2026
- Expected to end
- 15 Jul 2032
- Type of study
- Interventional, 4 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- Atorvastatin (Lipitor)
- Vitamin D
- Record updated
- 30 April 2026
Who can take part
- Age
- 20 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 7 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- Severe renal impairment, defined as an estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73 m²
- Pregnancy
Where in Taiwan
- Taipei Veterans General HospitalTaipei, TaiwanContact: Chin-Sung Kuo, MD, PhDTaking people
About the trial
What the trial wants to find out
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:
Read full original descriptionShow less
* 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
The 4 groups in the trial
- Standard CareNo study treatment, for comparison
Participants receive standard care for active thyroid eye disease according to current clinical practice for 24 weeks.
- StatinTreatment being tested
Participants receive standard care plus oral atorvastatin 20 mg once daily for 24 weeks.
Treatment: Atorvastatin (Lipitor)
- Vitamin DTreatment being tested
Participants receive standard care plus oral vitamin D supplementation at a dose of 1400 IU daily for 24 weeks.
- Statin plus Vitamin DTreatment being tested
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.
Treatment: Atorvastatin (Lipitor) and Vitamin D
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- The Role of Statin and Vitamin D for the Treatment of Thyroid Eye Disease
- Record updated
- 30 April 2026