Clinical Trial: Selenium Treatment in Autoimmune Thyroiditis (AIT)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:
Sponsor: Ege University

Current Primary Outcome: statistically important change in serum TPOAb titers.

Original Primary Outcome: Same as current

Current Secondary Outcome: Observe the long term effects to 9th mo.

Original Secondary Outcome: Same as current

Information By: Ege University

Dates:
Date Received: December 30, 2005
Date Started: December 2004
Date Completion: August 2005
Last Updated: August 22, 2006
Last Verified: December 2004