Statin and Vitamin D Treatment in Patients With Thyroid Eye Disease

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorTaipei Veterans General Hospital, Taiwan

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Factorial

Treatments tested in this trial

  • Atorvastatin (Lipitor)

    Drug

    Oral atorvastatin 20 mg administered once daily for 24 weeks.

  • Vitamin D

    Dietary supplement

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

Treatment groups

120 Participants
are divided into 4 treatment groups
Group A: Standard CareNo intervention 0 interventions
Group B: StatinExperimental treatment 1 intervention
Group C: Vitamin DExperimental treatment 1 intervention
Group D: Statin plus Vitamin DExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Change in Clinical Activity Score (CAS)

The Clinical Activity Score (CAS; range 0-7, with higher scores indicating greater disease activity)

Time frame
Baseline to 24 weeks
2

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)

Time frame
Baseline to 24 weeks
3

Change in Proptosis

Change in proptosis measured by Hertel exophthalmometry

Time frame
Baseline to 24 weeks
4

Change in Thyroid-Stimulating Immunoglobulin (TSI)

Change in serum thyroid-stimulating immunoglobulin (TSI) levels

Time frame
Baseline to 24 weeks

Secondary outcomes

1

Change in Thyroid Function

Change in thyroid function parameters (TSH, free T4, free T3)

Time frame
Baseline to 24 weeks
2

Change in Lipid Profile

Change in lipid parameters, including low-density lipoprotein cholesterol (LDL-C)

Time frame
Baseline to 24 weeks
3

Change in Blood Glucose

Change in blood glucose levels

Time frame
Baseline to 24 weeks
4

Concomitant Medication Use

Use of thyroid-related medications and systemic corticosteroids during the intervention period

Time frame
Baseline to 24 weeks

Other outcomes

Sponsors and contacts

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