Selenium in Mild Thyroid Eye Disease in North America

Columbia University

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Conditions

Thyroid Associated Ophthalmopathies

Interventions

Sodium selenateDRUG

A 100 microgram pill will be orally administered twice a day for 6 months.

Sugar pillDIETARY_SUPPLEMENT

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Difference in Quality of Life score

Using GO-QOL score

Time frame: Six months

Difference in Quality of Life score

GO-QOL score

Time frame: Twelve months

Change in Thyroid Eye Disease

Time frame: Six months

Change in Thyroid Eye Disease

Time frame: Twelve months

Secondary Outcomes

Difference in Clinical Activity Score

Time frame: Six months

Difference in Clinical Activity Score

Time frame: Twelve months

Difference in Quality of Life score

TED-PRO

Time frame: Six months

Difference in Quality of Life score

TED-PRO

Time frame: Twelve months

Difference in Quality of Life score

TED-QOL

Time frame: Six months

Difference in Quality of Life score

TED-QOL

Time frame: Twelve months

Difference in development of optic neuropathy

Time frame: Twelve months

Data from ClinicalTrials.gov

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