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| Name | Class |
|---|---|
| International Thyroid Eye Disease Society | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Selenium | Active Comparator | 100 micrograms of sodium selenate will be taken orally twice daily (total 200 micrograms daily) for 6 months. |
|
| Sugar pill | Placebo Comparator | A placebo pill will be taken orally twice daily for 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium selenate | Drug | A 100 microgram pill will be orally administered twice a day for 6 months. |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Clinical Activity Score | Six months | |
| Difference in Clinical Activity Score | Twelve months | |
| Difference in Quality of Life score |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting glucose level | Six months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Micahel Kazim, MD | International Thyroid Eye Disease Society | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21591944 | Background | Marcocci C, Kahaly GJ, Krassas GE, Bartalena L, Prummel M, Stahl M, Altea MA, Nardi M, Pitz S, Boboridis K, Sivelli P, von Arx G, Mourits MP, Baldeschi L, Bencivelli W, Wiersinga W; European Group on Graves' Orbitopathy. Selenium and the course of mild Graves' orbitopathy. N Engl J Med. 2011 May 19;364(20):1920-31. doi: 10.1056/NEJMoa1012985. |
| Label | URL |
|---|---|
| This is the International Thyroid Eye Disease Society (ITEDS) website. | View source |
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| ID | Term |
|---|---|
| D049970 | Graves Ophthalmopathy |
| ID | Term |
|---|---|
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D006111 | Graves Disease |
| D005094 | Exophthalmos |
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| ID | Term |
|---|---|
| D064586 | Selenic Acid |
| D012643 | Selenium |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D018036 | Selenium Compounds |
| D007287 | Inorganic Chemicals |
| D018011 | Chalcogens |
| D004602 | Elements |
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| Sugar pill | Dietary 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. |
|
|
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 |
| D009916 |
| Orbital Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006042 | Goiter |
| D013959 | Thyroid Diseases |
| D004700 | Endocrine System Diseases |
| D006980 | Hyperthyroidism |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D008903 |
| Minerals |
| D002241 | Carbohydrates |