Atorvastatin and vitamin D for active thyroid eye disease
Official title: The Role of Statin and Vitamin D for the Treatment of Thyroid Eye Disease
Run by Taipei Veterans General Hospital, Taiwan · NCT07400757 · Data updated 2026-11-12
This trial tests whether taking atorvastatin and/or vitamin D with usual care can reduce eye inflammation and bulging in adults with active thyroid eye disease.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 20 Years and up |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Taipei Veterans General Hospital, Taiwan Government |
| Locations | 1 site (Taipei, Taiwan) |
| Status | Recruiting |
| Started | February 24, 2026 |
| Main results expected | December 31, 2029 |
| Study ends | July 15, 2032 |
| Registry record updated | April 30, 2026 |
| Trial ID | NCT07400757 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 20 or older with active thyroid eye disease (CAS ≥3) and an LDL cholesterol of at least 100 mg/dL who are not pregnant, have not recently taken statins or high‑dose vitamin D, and do not have prior orbital radiotherapy or severe renal impairment are ideal candidates.
✕Probably not a fit
Patients in the inactive fibrotic phase of TED, those with LDL below 100 mg/dL, recent statin or high‑dose vitamin D use, pregnant individuals, those with severe renal impairment, or patients who previously had orbital surgery or radiotherapy are unlikely to be eligible or to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, four-arm trial will assign adults with active thyroid eye disease to standard care, atorvastatin plus standard care, vitamin D plus standard care, or both atorvastatin and vitamin D plus standard care for 24 weeks. Disease activity will be measured by Clinical Activity Score (CAS) and changes in proptosis, and safety and adverse events will be recorded. Key eligibility includes CAS ≥3 and LDL ≥100 mg/dL, while recent statin or high‑dose vitamin D use, prior orbital surgery or radiotherapy, pregnancy, and severe renal impairment are exclusion criteria. The study is conducted at Taipei Veterans General Hospital in Taipei, Taiwan.
Why it matters
Potential benefit: If effective, adding atorvastatin and/or vitamin D could reduce inflammation and eye protrusion and offer a safer adjunct to current therapies.
How similar studies have gone: Observational studies have linked statin use with lower TED risk and vitamin D deficiency is common in TED, but randomized data on these therapies, especially combined, are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where it's running
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Taipei Veterans General Hospital
Taipei, Taiwan, Taiwan Recruiting
Study contacts
- Principal investigator: Chin-Sung Kuo, MD, PhD — Taipei Veterans General Hospital, Taipei, Taiwan
- Study coordinator: Chin-Sung Kuo, MD, PhD
- Email: cskuo@vghtpe.gov.tw
- Phone: 886-2-28757513
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.