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Statin and Vitamin D Treatment in Patients With Thyroid Eye Disease

NCT07400757 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-04-30

No results posted yet for this study

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

Conditions

  • Thyroid Eye Disease, TED
  • Graves Ophthalmopathy

Interventions

DRUG

Atorvastatin (Lipitor)

Oral atorvastatin 20 mg administered once daily for 24 weeks.

DIETARY_SUPPLEMENT

Vitamin D

Oral vitamin D supplementation at a dose of 1400 IU administered once daily for 24 weeks.

Sponsors & Collaborators

  • Taipei Veterans General Hospital, Taiwan

    lead OTHER_GOV

Principal Investigators

  • Chin-Sung Kuo, MD, PhD · Taipei Veterans General Hospital, Taipei, Taiwan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-24
Primary Completion
2029-12-31
Completion
2032-07-15

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07400757 on ClinicalTrials.gov