NCT07400757 Statin and Vitamin D Treatment in Patients With Thyroid Eye Disease
| NCT ID | NCT07400757 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Taipei Veterans General Hospital, Taiwan |
| Condition | Thyroid Eye Disease, TED |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2026-02-24 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2026-02-24 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Eligibility 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
Contact & Investigator
Chin-Sung Kuo, MD, PhD
PRINCIPAL INVESTIGATOR
Taipei Veterans General Hospital, Taipei, Taiwan
Frequently Asked Questions
Who can join the NCT07400757 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, studying Thyroid Eye Disease, TED. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07400757 currently recruiting?
Yes, NCT07400757 is actively recruiting participants. Contact the research team at cskuo@vghtpe.gov.tw for enrollment information.
Where is the NCT07400757 trial being conducted?
This trial is being conducted at Taipei, Taiwan.
Who is sponsoring the NCT07400757 clinical trial?
NCT07400757 is sponsored by Taipei Veterans General Hospital, Taiwan. The principal investigator is Chin-Sung Kuo, MD, PhD at Taipei Veterans General Hospital, Taipei, Taiwan. The trial plans to enroll 120 participants.