Selenium in Mild Thyroid Eye Disease in North America

Study Overview
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Brief Summary
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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
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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.

Official Title
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Selenium - ITEDS: A North American Study

Conditions
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Thyroid Associated Ophthalmopathies

Intervention / Treatment
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* Drug: Sodium selenate
* Dietary Supplement: Sugar pill


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Selenium<br>100 micrograms of sodium selenate will be taken orally twice daily (total 200 micrograms daily) for 6 months. | Drug: Sodium selenate<br>* A 100 microgram pill will be orally administered twice a day for 6 months.<br>* Other names: Selenium;|
| Placebo Comparator: Sugar pill<br>A placebo pill will be taken orally twice daily for 6 months. | Dietary Supplement: Sugar pill<br>* 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.<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Quality of Life score | Using GO-QOL score | Six months | 
| Difference in Quality of Life score | GO-QOL score | Twelve months | 
| Change in Thyroid Eye Disease |  | Six months | 
| Change in Thyroid Eye Disease |  | Twelve months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Clinical Activity Score |  | Six months | 
| Difference in Clinical Activity Score |  | Twelve months | 
| Difference in Quality of Life score | TED-PRO | Six months | 
| Difference in Quality of Life score | TED-PRO | Twelve months | 
| Difference in Quality of Life score | TED-QOL | Six months | 
| Difference in Quality of Life score | TED-QOL | Twelve months | 
| Difference in development of optic neuropathy |  | Twelve months | 
| Difference in Inflammatory Index | Improvement | Six months | 
| Difference in Inflammatory Index | Improvement | Twelve months | 
| Difference in Inflammatory Index | Deterioration | Six months | 
| Difference in Inflammatory Index | Deterioration | Twelve months | 
| Difference in diplopia score | Improvement | Six months | 
| Difference in diplopia score | Improvement | Twelve months | 
| Difference in diplopia score | Deterioration | Six months | 
| Difference in diplopia score | Deterioration | Twelve months | 
| Difference in degrees of restriction | Improvement | Six months | 
| Difference in degrees of restriction | Improvement | Twelve months | 
| Difference in degrees of restriction | Deterioration | Six months | 
| Difference in degrees of restriction | Deterioration | Twelve months | 
| Difference in exophthalmos scores | Improvement | Six months | 
| Difference in exophthalmos scores | Improvement | Twelve months | 
| Difference in exophthalmos scores | Deterioration | Six months | 
| Difference in exophthalmos scores | Deterioration | Twelve months | 
| Difference in eyelid aperture | Improvement | Six months | 
| Difference in eyelid aperture | Improvement | Twelve months | 
| Difference in eyelid aperture | Deterioration | Six months | 
| Difference in eyelid aperture | Deterioration | Twelve months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thyroid eye disease, Thyroid orbitopathy, Graves' orbitopathy, Graves' ophthalmopathy