The Role of Statin and Vitamin D for the Treatment of Thyroid Eye Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in Proptosis
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This is an open-label study. Neither the participants nor the investigators are blinded to treatment assignment.
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Vitamin D
Participants receive standard care plus oral vitamin D supplementation at a dose of 1400 IU daily for 24 weeks.
干预措施: Vitamin D (Dietary Supplement)
Standard Care
Participants receive standard care for active thyroid eye disease according to current clinical practice for 24 weeks.
Statin
Participants receive standard care plus oral atorvastatin 20 mg once daily for 24 weeks.
干预措施: Atorvastatin (Lipitor) (Drug)
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.
干预措施: Atorvastatin (Lipitor) (Drug)
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.
干预措施: Vitamin D (Dietary Supplement)
结局指标
主要结局
Change in Proptosis
时间窗: Baseline to 24 weeks
Change in proptosis measured by Hertel exophthalmometry
Change in Thyroid-Stimulating Immunoglobulin (TSI)
时间窗: Baseline to 24 weeks
Change in serum thyroid-stimulating immunoglobulin (TSI) levels
Change in Clinical Activity Score (CAS)
时间窗: 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)
时间窗: 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)
次要结局
- Change in Thyroid Function(Baseline to 24 weeks)
- Change in Lipid Profile(Baseline to 24 weeks)
- Change in Blood Glucose(Baseline to 24 weeks)
- Concomitant Medication Use(Baseline to 24 weeks)