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