Statin and Vitamin D Treatment in Patients With Thyroid Eye Disease

April 24, 2026 updated by: Taipei Veterans General Hospital, Taiwan

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Thyroid eye disease (TED) is an autoimmune inflammatory disorder commonly associated with Graves' disease. The disease typically follows an active inflammatory phase, characterized by orbital inflammation, pain, redness, swelling, and progression of eye protrusion, followed by an inactive fibrotic phase with more permanent structural changes. Early intervention during the active phase is critical to reduce disease severity and prevent long-term functional and cosmetic complications.

Current treatments for active TED primarily focus on immunosuppression, such as systemic corticosteroids or other immunomodulatory therapies. However, these treatments may be associated with significant side effects and variable treatment responses. Therefore, there is an unmet need for adjunctive therapies with favorable safety profiles that may modify disease activity and change outcomes in patients with active TED.

Recent observational studies have suggested that statin use is associated with a lower risk of developing thyroid eye disease and a reduced severity of disease manifestations. These potential benefits appear to be independent of cholesterol-lowering effects and may be related to the anti-inflammatory and immunomodulatory properties of statins. In addition, vitamin D deficiency has been frequently observed in patients with TED, and vitamin D is known to play a role in immune regulation and inflammatory control. Experimental and clinical studies suggest that vitamin D supplementation may modulate autoimmune activity and modify inflammatory responses.

Despite these findings, there is limited prospective clinical trial evidence evaluating the effects of statin therapy and vitamin D supplementation in patients with active TED. This study is designed as a randomized, open-label, 2×2 factorial clinical trial to evaluate the individual and combined effects of statin therapy and vitamin D supplementation on disease activity in patients with active TED.

Eligible participants with active TED will be randomly assigned to one of four groups: standard care alone, standard care plus statin therapy, standard care plus vitamin D supplementation, or standard care plus combined statin and vitamin D therapy. The intervention period will last for 24 weeks. Statin therapy consists of oral atorvastatin 20 mg once daily, and vitamin D supplementation consists of oral vitamin D at a daily dose of 1400 IU.

The primary outcomes of the study include changes in the Clinical Activity Score (CAS), responder rate defined as a ≥2-point change in Clinical Activity Score (CAS), changes in proptosis measured by Hertel exophthalmometry, and changes in thyroid-stimulating immunoglobulin (TSI) levels from baseline to 24 weeks. Secondary outcomes include changes in thyroid function, lipid profiles, blood glucose levels, and the use of thyroid-related medications and systemic corticosteroids during the intervention period.

Safety assessments will be conducted throughout the study by monitoring clinical symptoms, laboratory parameters, and reported adverse events. After completion of the 24-week intervention, participants will return to standard care and will be followed through medical record review for up to three years to observe long-term disease activity outcomes.

This study aims to provide prospective clinical evidence regarding the potential role of statin therapy and vitamin D supplementation as adjunctive treatments for active thyroid eye disease.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
    • Taiwan
      • Taipei, Taiwan, Taiwan, 11217
        • Recruiting
        • Taipei Veterans General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard Care
Participants receive standard care for active thyroid eye disease according to current clinical practice for 24 weeks.
Experimental: Statin
Participants receive standard care plus oral atorvastatin 20 mg once daily for 24 weeks.
Drug: Atorvastatin (Lipitor)
Oral atorvastatin 20 mg administered once daily for 24 weeks.
Experimental: Vitamin D
Participants receive standard care plus oral vitamin D supplementation at a dose of 1400 IU daily for 24 weeks.
Dietary supplement: Vitamin D
Oral vitamin D supplementation at a dose of 1400 IU administered once daily for 24 weeks.
Experimental: Statin plus Vitamin D
Participants receive standard care plus oral atorvastatin 20 mg once daily and oral vitamin D supplementation at a dose of 1400 IU daily for 24 weeks.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Proptosis
Time Frame: Baseline to 24 weeks
Change in proptosis measured by Hertel exophthalmometry
Baseline to 24 weeks
Change in Thyroid-Stimulating Immunoglobulin (TSI)
Time Frame: Baseline to 24 weeks
Change in serum thyroid-stimulating immunoglobulin (TSI) levels
Baseline to 24 weeks
Change in Clinical Activity Score (CAS)
Time Frame: Baseline to 24 weeks
The Clinical Activity Score (CAS; range 0-7, with higher scores indicating greater disease activity)
Baseline to 24 weeks
Change in Thyroid Eye Disease Activity (Responder Analysis)
Time Frame: Baseline to 24 weeks
Proportion of participants achieving a ≥2-point change in the Clinical Activity Score (CAS; range 0-7, with higher scores indicating greater disease activity)
Baseline to 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Thyroid Function
Time Frame: Baseline to 24 weeks
Change in thyroid function parameters (TSH, free T4, free T3)
Baseline to 24 weeks
Change in Lipid Profile
Time Frame: Baseline to 24 weeks
Change in lipid parameters, including low-density lipoprotein cholesterol (LDL-C)
Baseline to 24 weeks
Change in Blood Glucose
Time Frame: Baseline to 24 weeks
Change in blood glucose levels
Baseline to 24 weeks
Concomitant Medication Use
Time Frame: Baseline to 24 weeks
Use of thyroid-related medications and systemic corticosteroids during the intervention period
Baseline to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Veterans General Hospital, Taiwan

Investigators

  • Principal Investigator: Chin-Sung Kuo, MD, PhD, Taipei Veterans General Hospital, Taipei, Taiwan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 24, 2026

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

July 15, 2032

Study Registration Dates

First Submitted

February 3, 2026

First Submitted That Met QC Criteria

February 3, 2026

First Posted (Actual)

February 10, 2026

Study Record Updates

Last Update Posted (Actual)

April 30, 2026

Last Update Submitted That Met QC Criteria

April 24, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-08-018A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared due to institutional data protection policies and ethical considerations related to participant privacy.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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