Clinical trial NCT02112643: Selenium in Mild Thyroid Eye Disease in North America
Official title: Selenium - ITEDS: A North American Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Thyroid Associated Ophthalmopathies
Keywords: Thyroid eye disease
Thyroid orbitopathy
Graves' orbitopathy
Graves' ophthalmopathy
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: International Thyroid Eye Disease Society
First posted: 2014-04-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Difference in Quality of Life score
timeFrame: Six months
measure: Difference in Quality of Life score
timeFrame: Twelve months
measure: Change in Thyroid Eye Disease
timeFrame: Six months
measure: Change in Thyroid Eye Disease
timeFrame: Twelve months
Secondary outcomes:
measure: Difference in Clinical Activity Score
timeFrame: Six months
measure: Difference in Clinical Activity Score
timeFrame: Twelve months
measure: Difference in Quality of Life score
timeFrame: Six months
measure: Difference in Quality of Life score
timeFrame: Twelve months
measure: Difference in Quality of Life score
timeFrame: Six months
measure: Difference in Quality of Life score
timeFrame: Twelve months
measure: Difference in development of optic neuropathy
timeFrame: Twelve months
measure: Difference in Inflammatory Index
timeFrame: Six months
measure: Difference in Inflammatory Index
timeFrame: Twelve months
measure: Difference in Inflammatory Index
timeFrame: Six months
measure: Difference in Inflammatory Index
timeFrame: Twelve months
measure: Difference in diplopia score
timeFrame: Six months
measure: Difference in diplopia score
timeFrame: Twelve months
measure: Difference in diplopia score
timeFrame: Six months
measure: Difference in diplopia score
timeFrame: Twelve months
measure: Difference in degrees of restriction
timeFrame: Six months
measure: Difference in degrees of restriction
timeFrame: Twelve months
measure: Difference in degrees of restriction
timeFrame: Six months
measure: Difference in degrees of restriction
timeFrame: Twelve months
measure: Difference in exophthalmos scores
timeFrame: Six months
measure: Difference in exophthalmos scores
timeFrame: Twelve months
measure: Difference in exophthalmos scores
timeFrame: Six months
measure: Difference in exophthalmos scores
timeFrame: Twelve months
measure: Difference in eyelid aperture
timeFrame: Six months
measure: Difference in eyelid aperture
timeFrame: Twelve months
measure: Difference in eyelid aperture
timeFrame: Six months
measure: Difference in eyelid aperture
timeFrame: Twelve months
Other outcomes:
measure: Fasting glucose level
timeFrame: Six months
Locations:
Study officials:
affiliation: International Thyroid Eye Disease Society
name: Micahel Kazim, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.