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

What this Trial Is About

Researchers are investigating whether statin therapy and vitamin D supplements can change disease activity in patients with active thyroid eye disease (TED), an autoimmune condition linked to Graves' disease. The study also looks at the safety of these treatments. It aims to answer whether statin or vitamin D alone or combined with standard care can reduce disease signs like inflammation and eye protrusion, compared to standard care alone. Participants are randomly assigned to one of four groups: standard care only, standard care plus atorvastatin 20 mg daily, standard care plus vitamin D 1400 IU daily, or both atorvastatin and vitamin D with standard care. Treatments last for 24 weeks. After this period, participants return to standard care and are followed through medical record reviews for up to three years to assess long-term outcomes. During the study, participants will attend clinic visits at the start and end of treatment for clinical assessments and blood tests. Researchers will monitor changes in the Clinical Activity Score (CAS), eye protrusion, thyroid-stimulating immunoglobulin levels, thyroid function, lipid profiles, and blood glucose. Safety is checked throughout by tracking symptoms, lab tests, and possible side effects. The entire follow-up period extends up to three years after treatment ends.

Statin and Vitamin D Treatment in Patients With Thyroid Eye Disease