Effect of Supplementation of Two Doses of L-selenomethionine (Semet; 80 and 160 mcg) Versus Placebo in Patients With Chronic Autoimmune Thyroiditis (AIT) With Normal Thyroid Function.
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 主要终点
- Improvement of thyroid echogenicity
研究概览
简要总结
Over the past 10 years, several clinical studies have suggested that selenium supplementation may influence the natural history of AIT. Recently, Interferon gamma (IFNγ)-inducible chemokines (CXCL-9, -10 and -11) were shown to be elevated in the AIT patients. The aim of this prospective, randomized, controlled study is to evaluate the effect of two different doses of selenomethionine (80 or 160 mcg) versus placebo in euthyroid women with AIT, in terms of reduction of anti-thyroid antibodies and improvement of thyroid hypoechogenicity, over 24 months. Serum levels of selenium, CXCL-9, -10 and -11 and their regulators, Tumor necrosis factor alpha (TNFα) and INFγ, thyroid function and volume and the quality of life of AIT patients are also evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of chronic autoimmune thyroiditis defined by positivity of anti thyroperoxidase and/or anti thyroglobulin antibodies (> or = 100 U/l) and thyroid hypoechogenicity
排除标准
- •Presence of other thyroid disease but micronodules
- •History of the malignancy in the past 5 years
- •Drugs affecting immune system and/or thyroid function
- •Pregnancy detected during screening or follow-up.
结局指标
主要结局
Improvement of thyroid echogenicity
时间窗: 12 months
High-resolution sonograhic images are captured, converted into a spectrum of gray-scale pixels (gsp) ranging from 0 (lowest echogenicity) to 255 (highest echogenicity) and a mean value is then obtained. Any statistically significant increase of the gsp compared to the baseline is considered an improvement relevant to the study outcome.
Reduction of anti-thyroid antibodies
时间窗: 12 months
Anti thyroperoxidase and thyroglobulin antibodies are measured by a chemiluminescent assay. Any statistically significant decrease of one or both antibody values compared to the baseline is considered a reduction relevant to the study outcome.
次要结局
- Prevention or reduction of the incidence of hypothyroidism(24 months)
研究者
Furio Pacini
Full Professor
University of Siena