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Clinical Trial Summary

The purpose of this study is to determine whether sodium selenite is helpful in the treatment of mild thyroid eye disease in North America.


Clinical Trial Description

Thyroid eye disease (TED) is a disease in which the soft tissues surrounding the eye can become inflamed, scarred, and at times permanently damaged in an autoimmune reaction highly associated with abnormal thyroid hormone levels. Some patients have much more severe TED than others, but overall, most patients reach a point with relatively stable TED after 1 to 2 years. A recent European study showed that oral selenium, a trace mineral involved in anti-oxidation and immune regulation, could actually alter the course of mild TED, lessening its signs and symptoms and even improving the quality of life of those who took it. The investigators would like to perform a sister study throughout North America. In this randomized, double-blinded, multi-center trial, some subjects with mild TED would be given 100 micrograms of sodium selenite twice a day; others would receive a placebo. Signs, symptoms, and quality of life would be measured at regular intervals throughout the 6 month period of drug administration, and for 6 months thereafter. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02112643
Study type Interventional
Source Columbia University
Contact
Status Withdrawn
Phase Phase 3
Start date October 2015
Completion date November 16, 2016

See also
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Completed NCT01868997 - Teprotumumab (RV 001) Treatment in Patients With Active Thyroid Eye Disease Phase 2