NCT02112643

Selenium in Mild Thyroid Eye Disease in North America

Selenium - ITEDS: A North American Study

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Thyroid Associated Ophthalmopathies

Interventions

Type	Name	Description
DRUG	Sodium selenate	A 100 microgram pill will be orally administered twice a day for 6 months.
DIETARY_SUPPLEMENT	Sugar pill	The placebo pill will be constructed to look exactly like the selenium pill, but will have no active ingredients. This will be orally administered for 6 months.

Timeline

• Start date: 2015-10-01
• Primary completion: 2016-11-16
• Completion: 2016-11-16
• First posted: 2014-04-14
• Last updated: 2021-08-18

Regulatory

• FDA-regulated drug study