Thyroid Eye Disease, TEDNCT07400757
Statin and Vitamin D Treatment in Patients With Thyroid Eye Disease
A study testing Atorvastatin (Lipitor) and Vitamin D in people with Thyroid Eye Disease, TED and Graves Ophthalmopathy, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Thyroid Eye Disease, TED, Graves Ophthalmopathy
- What is being tested?
- Atorvastatin (Lipitor) and Vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 24 Feb 2026to 15 Jul 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Veterans General Hospital
Taipei, Taiwan, 11217
Chin-Sung Kuo, MD, PhD, 886-2-28757513, cskuo@vghtpe.gov.tw
About this study
Official title: 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?
Read more
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
Read the 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.
- Conditions
- Thyroid Eye Disease, TED, Graves Ophthalmopathy
- Being tested
- Atorvastatin (Lipitor), Vitamin D
- Keywords
- Thyroid Eye Disease, Graves Ophthalmopathy, Statin, Vitamin D, Atorvastatin, Autoimmune Disease, Inflammation, Randomized Controlled Trial, Factorial Design, Clinical Activity Score
- Medical subject headings
- Graves Ophthalmopathy, Autoimmune Diseases, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atorvastatin (Lipitor)Drug
Oral atorvastatin 20 mg administered once daily for 24 weeks.
Vitamin DDietary supplement
Oral vitamin D supplementation at a dose of 1400 IU administered once daily for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | No intervention | Participants receive standard care for active thyroid eye disease according to current clinical practice for 24 weeks. |
| Statin | Experimental | Participants receive standard care plus oral atorvastatin 20 mg once daily for 24 weeks. Receives: Drug: Atorvastatin (Lipitor) |
| Vitamin D | Experimental | Participants receive standard care plus oral vitamin D supplementation at a dose of 1400 IU daily for 24 weeks. Receives: Dietary Supplement: Vitamin D |
| Statin plus Vitamin D | Experimental | 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. Receives: Drug: Atorvastatin (Lipitor); Dietary Supplement: Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Clinical Activity Score (CAS)
The Clinical Activity Score (CAS; range 0-7, with higher scores indicating greater disease activity)
Measured: Baseline to 24 weeks
Change in Thyroid Eye Disease Activity (Responder Analysis)
Proportion of participants achieving a ≥2-point change in the Clinical Activity Score (CAS; range 0-7, with higher scores indicating greater disease activity)
Measured: Baseline to 24 weeks
Change in Proptosis
Change in proptosis measured by Hertel exophthalmometry
Measured: Baseline to 24 weeks
Change in Thyroid-Stimulating Immunoglobulin (TSI)
Change in serum thyroid-stimulating immunoglobulin (TSI) levels
Measured: Baseline to 24 weeks
Secondary outcomes (4)
Change in Thyroid Function
Change in thyroid function parameters (TSH, free T4, free T3)
Measured: Baseline to 24 weeks
Change in Lipid Profile
Change in lipid parameters, including low-density lipoprotein cholesterol (LDL-C)
Measured: Baseline to 24 weeks
Change in Blood Glucose
Change in blood glucose levels
Measured: Baseline to 24 weeks
Concomitant Medication Use
Use of thyroid-related medications and systemic corticosteroids during the intervention period
Measured: Baseline to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start24 Feb 2026
- Primary completion31 Dec 2029 (estimated)
- Study completion15 Jul 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Thyroid Eye Disease, TEDStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- This study uses a 2×2 factorial, parallel-group design to evaluate the independent and combined effects of statin therapy and vitamin D supplementation. Participants are randomly assigned to one of four groups: standard care alone, statin plus standard care, vitamin D plus standard care, or combined statin and vitamin D plus standard care.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Chin-Sung Kuo, MD, PhD, Principal investigator, Taipei Veterans General Hospital, Taipei, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07400757
- Sponsor's protocol ID
- 2025-08-018A
- Status last verified
- Apr 2026
- First submitted
- 3 Feb 2026
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to institutional data protection policies and ethical considerations related to participant privacy.
Publications
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.
PubMed 39819487Chou 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.
PubMed 39804287Wang 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.
PubMed 39949783
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Statin and Vitamin D for the Treatment of Thyroid Eye Disease
- ClinicalTrials.gov ID
- NCT07400757
- Acronym / sponsor ID
- 2025-08-018A
- Conditions
- Thyroid Eye Disease, TED, Graves Ophthalmopathy
- Keywords
- Thyroid Eye Disease, Graves Ophthalmopathy, Statin, Vitamin D, Atorvastatin, Autoimmune Disease, Inflammation, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 24 Feb 2026 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 15 Jul 2032 (estimated)
- First posted
- 10 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This study uses a 2×2 factorial, parallel-group design to evaluate the independent and combined effects of statin therapy and vitamin D supplementation. Participants are randomly assigned to one of four groups: standard care alone, statin plus standard care, vitamin D plus standard care, or combined statin and vitamin D plus standard care.
| Arm | Type | Receives |
|---|---|---|
| Standard Care | No intervention | –Participants receive standard care for active thyroid eye disease according to current clinical practice for 24 weeks. |
| Statin | Experimental | Drug: Atorvastatin (Lipitor)Participants receive standard care plus oral atorvastatin 20 mg once daily for 24 weeks. |
| Vitamin D | Experimental | Dietary Supplement: Vitamin DParticipants receive standard care plus oral vitamin D supplementation at a dose of 1400 IU daily for 24 weeks. |
| Statin plus Vitamin D | Experimental | Drug: Atorvastatin (Lipitor), Dietary Supplement: Vitamin DParticipants 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atorvastatin (Lipitor)Oral atorvastatin 20 mg administered once daily for 24 weeks. | Drug | Statin, Statin plus Vitamin D |
| Vitamin DOral vitamin D supplementation at a dose of 1400 IU administered once daily for 24 weeks. | Dietary supplement | Statin plus Vitamin D, Vitamin D |
Primary outcome
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)
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)
Change in Proptosis
Time frame: Baseline to 24 weeks
Change in proptosis measured by Hertel exophthalmometry
Change in Thyroid-Stimulating Immunoglobulin (TSI)
Time frame: Baseline to 24 weeks
Change in serum thyroid-stimulating immunoglobulin (TSI) levels
4 secondary outcomes
Change in Thyroid Function
Time frame: Baseline to 24 weeks
Change in Lipid Profile
Time frame: Baseline to 24 weeks
Change in Blood Glucose
Time frame: Baseline to 24 weeks
Concomitant Medication Use
Time frame: Baseline to 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Background: PubMed 39819487Cardo 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: PubMed 39804287Chou 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: PubMed 39949783Wang 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to institutional data protection policies and ethical considerations related to participant privacy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chin-Sung Kuo, MD, PhD principal investigator
Taipei Veterans General Hospital, Taipei, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atorvastatin (Lipitor) and Vitamin D in people with Thyroid Eye Disease, TED and Graves Ophthalmopathy, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chin-Sung Kuo, MD, PhD (886-2-28757513, cskuo@vghtpe.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Clinical Activity Score (CAS) (time frame: Baseline to 24 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07400757, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.