跳至主要内容
临床试验/NCT00271427
NCT00271427已完成不适用

Selenium Treatment in Autoimmune Thyroiditis: Long Term Follow-Up With Variable Doses

Ege University2 个研究点 分布在 2 个国家目标入组 100 人开始时间: 2004年12月最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
statistically important change in serum TPOAb titers.

研究概览

简要总结

Selenium suppresses autoimmune destruction of thyrocytes and decreases titers of serum TPOAb in AIT patients. Older 4 clinical trials approved the efficacy of the daily dose of 200micg. It's believed that Se saturates the deficient stores of GPX so GPX saves the thyrocytes against to oxidative stresses. Although less than 70 micg/d is sufficient to maximize GPX activity, none of the authors tested the doses less than 200 micg/d. Our hypothesis was that If 100 micg/d can not suppress the TPOAb titers,it means autoimmune destruction can not be blocked by saturation of deficient stores of GPX solely and the mechanism of action requires more than repletion of deficient stores. It's important not only to estimate the optimal dose but to understand the mechanism of action. High dose therapy may also suppress TPOAb levels in Se-non-deficient AIT patients, if it is so, Se therapy may becomes the solely treatment modality which can suppress the autoimmunity in more than 400 million AIT patients. Because there've been no way to suppress autoimmune war and replacement of LT4 had been the only treatment modality for palliation. An other independent part of the study is to test the effect of Se in adolescent AIT patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double

入排标准

年龄范围
15 Years 至 70 Years(Child, Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Clinically approved AIT patients who do not use any medication other than LT4 to keep TSH in the lower half of normal range.

排除标准

  • Any kind of drug use other than LT4 or any kind of known pathology which may effect GIS absorption.

结局指标

主要结局

statistically important change in serum TPOAb titers.

次要结局

  • Observe the long term effects to 9th mo.

研究者

申办方类型
Other

研究点 (2)

Loading locations...

相似试验