Selenium in Mild Thyroid Eye Disease in North America

Phase 3

Withdrawn

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

Age 18 or older
Able to provide informed consent
Able to swallow pills
Mild thyroid eye disease requiring no past treatment other than ophthalmic drops or ointment
Euthyroid: at least 2 months if on medication irregardless of thyroidectomy status; at least 6 months after radioiodine therapy; if euthyroid for the year prior to enrollment, needs normal thyroid-stimulating hormone (TSH) within last 3 months; if uncontrolled for the year prior to enrollment, needs normal TSH and free T4 within last 3 months; if TSH low, needs normal T3 and free T4
If you are currently taking any selenium supplementation, you will be asked to discontinue its usage, "wash out", for 1 month before you are enrolled.

Exclusion Criteria

Moderate or severe thyroid eye disease (based upon International Thyroid Eye Disease Society VISA form), including: grade 2 chemosis or lid edema; corneal exposure with threat of or resulting in perforation; optic neuropathy; grade 3 restriction of any extraocular muscle
Double vision (diplopia) in primary or reading positions
Duration of thyroid eye disease greater than 12 months (as per patient history)
Drug or alcohol abuse
Severe systemic illness (defined by treating physician)
Pregnant or breastfeeding

Arm && Interventions

Group	Intervention	Description
Selenium	Sodium selenate	100 micrograms of sodium selenate will be taken orally twice daily (total 200 micrograms daily) for 6 months.
Sugar pill	Sugar pill	A placebo pill will be taken orally twice daily for 6 months.

Primary Outcome Measures

Name	Time	Method
Change in Thyroid Eye Disease	Twelve months
Difference in Quality of Life score	Twelve months	GO-QOL score

Secondary Outcome Measures

Name	Time	Method
Difference in development of optic neuropathy	Twelve months
Difference in diplopia score	Twelve months	Deterioration
Difference in degrees of restriction	Twelve months	Deterioration
Difference in exophthalmos scores	Twelve months	Deterioration
Difference in eyelid aperture	Twelve months	Deterioration
Difference in Clinical Activity Score	Twelve months
Difference in Quality of Life score	Twelve months	TED-QOL
Difference in Inflammatory Index	Twelve months	Deterioration

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