Statin and Vitamin D Treatment in Patients With Thyroid Eye Disease
Summary
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
Timeline
- Start
- 2026-02-24
- Primary completion
- 2029-12-31
- Completion
- 2032-07-15
Publications
- Background Cardo C, Bernardo Santos R, Pinotti Pedro Miklos AB, Barbosa Jaconis S, Romaldini JH, Villagelin D. The relationship between cholesterol levels and thyroid eye disease. Eur Thyroid J. 2025 Feb 3;14(1):e240133. doi: 10.1530/ETJ-24-0133. Print 2025 Feb 1.
- Background Chou YT, Lai CC, Li CY, Shen WC, Huang YT, Wu YL, Lin YH, Yang DC, Yang YC. Statin Use and the Risk of Graves' Orbitopathy: A Nationwide Population-Based Cohort Study. Thyroid. 2025 Feb;35(2):199-207. doi: 10.1089/thy.2024.0536. Epub 2025 Jan 13.
- Background Wang CM, Chen YJ, Yang BC, Yang JW, Wang W, Zeng Y, Jiang J. Supplementation with active vitamin D3 ameliorates experimental autoimmune thyroiditis in mice by modulating the differentiation and functionality of intrathyroidal T-cell subsets. Front Immunol. 2025 Jan 30;16:1528707. doi: 10.3389/fimmu.2025.1528707. eCollection 2025.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atorvastatin | Small molecule | 20 mg | Oral |
| Subject | Vitamin D | Other / unclassified | 1400 iu | Oral |