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
This trial does not accept healthy volunteersQualifiers
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
Factorial
Treatments tested in this trial
Atorvastatin (Lipitor)
DrugOral atorvastatin 20 mg administered once daily for 24 weeks.
Vitamin D
Dietary supplementOral vitamin D supplementation at a dose of 1400 IU administered once daily for 24 weeks.
Treatment groups
Trial outcomes
Primary outcomes
Change in Clinical Activity Score (CAS)
The Clinical Activity Score (CAS; range 0-7, with higher scores indicating greater disease activity)
Change in Thyroid Eye Disease Activity (Responder Analysis)
Proportion of participants achieving a ≥2-point change in the Clinical Activity Score (CAS; range 0-7, with higher scores indicating greater disease activity)
Change in Proptosis
Change in proptosis measured by Hertel exophthalmometry
Change in Thyroid-Stimulating Immunoglobulin (TSI)
Change in serum thyroid-stimulating immunoglobulin (TSI) levels
Secondary outcomes
Change in Thyroid Function
Change in thyroid function parameters (TSH, free T4, free T3)
Change in Lipid Profile
Change in lipid parameters, including low-density lipoprotein cholesterol (LDL-C)
Change in Blood Glucose
Change in blood glucose levels
Concomitant Medication Use
Use of thyroid-related medications and systemic corticosteroids during the intervention period
Sponsors and contacts
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