Oral Supplementation With Selenium in Patients With Mild Thyroid Orbitopathy to Reduce Its
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 主要终点
- Clinical Activity Score (CAS)
研究概览
简要总结
Background: The activity of thyroid orbitopathy can be evaluated with CAS (Clinical Activity Score) based on 7 inflammatory signs. Selenium acts as an oxide-reducing agent in thioredoxin-reductase, and as an anti-inflammatory agent by reducing the hydroxy peroxide intermediates on the cyclo-oxygenase pathways. Increased oxidative stress has been observed in Graves' disease and therefore, by incorporating an antioxidant such as selenium in patients with mild thyroid ophthalmopathy, inflammatory activity could be reduced or inactivated.
General Objective: To determine the clinical differences between patients with mild thyroid orbitopathy who were administered oral supplementation with selenium and patients who were administered oral placebo.
详细描述
This is a simple controlled clinical trial. In which 66 eyes of 33 patients were studied. Fifteen patients were assigned to the placebo group and 18 to the Selenium group. We randomized into two groups the patients with mild clinical activity according to CAS score. Group A took placebo pills twice a day which consisted in 100µg of starch, and Group B took a pill of Selenium 100 µg twice a day. All the subjects tool the pills during six months. Patients of both groups where examined and evaluated with CAS score before and after the first, third and sixth month of treatment.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with active mild thyroid orbitopathy according to CAS scale.
- •Older than 18 years of age.
排除标准
- •Patients with mild thyroid orbitopathy undergoing treatment with corticosteroids.
- •Active smokers
- •Patients allergic to Selenium
- •Follow-up shorter than 6 months
研究组 & 干预措施
Group A, Placebo group
Placebo consisted in a pill of 100 micrograms of starch, to be taken twice a day.
干预措施: Placebo (Other)
Group B, Selenium group
Selenium consisted in a pill of 100 micrograms, to be taken twice a day.
干预措施: Selenium (Dietary Supplement)
结局指标
主要结局
Clinical Activity Score (CAS)
时间窗: 6 months after treatment
Clinical Activity Score (CAS) scale consists of 7 measurements used to evaluate clinical activity of thyroid orbitopathy: 1. Spontaneus orbital pain 2. Gaze evoked orbital pain 3. Conjunctival redness that is considered to be due to active GO 4. Eyelid erythema 5. Chemosis 6. Eyelid swelling that is considered to be due to active GO 7. Inflammation of plica or caruncle
次要结局
未报告次要终点