Selenium in Mild Thyroid Eye Disease in North America

Thyroid Associated Ophthalmopathies Clinical Trial

— S-ITEDS  

Official title:

Selenium - ITEDS: A North American Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02112643
• Other study ID #: AAAL9502
• Status: Withdrawn
• Phase: Phase 3
• Start date: October 2015
• Est. completion date: November 16, 2016

Study information

• Verified date: August 2021
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 16, 2016
• Est. primary completion date: November 16, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Eye Diseases
• Graves Ophthalmopathy
• Thyroid Associated Ophthalmopathies
• Thyroid Diseases

Intervention

Drug:
• Sodium selenate
A 100 microgram pill will be orally administered twice a day for 6 months.

Dietary Supplement:
• Sugar pill
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	International Thyroid Eye Disease Society

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Fasting glucose level		Six months
Primary	Difference in Quality of Life score	Using GO-QOL score	Six months
Primary	Difference in Quality of Life score	GO-QOL score	Twelve months
Primary	Change in Thyroid Eye Disease		Six months
Primary	Change in Thyroid Eye Disease		Twelve months
Secondary	Difference in Clinical Activity Score		Six months
Secondary	Difference in Clinical Activity Score		Twelve months
Secondary	Difference in Quality of Life score	TED-PRO	Six months
Secondary	Difference in Quality of Life score	TED-PRO	Twelve months
Secondary	Difference in Quality of Life score	TED-QOL	Six months
Secondary	Difference in Quality of Life score	TED-QOL	Twelve months
Secondary	Difference in development of optic neuropathy		Twelve months
Secondary	Difference in Inflammatory Index	Improvement	Six months
Secondary	Difference in Inflammatory Index	Improvement	Twelve months
Secondary	Difference in Inflammatory Index	Deterioration	Six months
Secondary	Difference in Inflammatory Index	Deterioration	Twelve months
Secondary	Difference in diplopia score	Improvement	Six months
Secondary	Difference in diplopia score	Improvement	Twelve months
Secondary	Difference in diplopia score	Deterioration	Six months
Secondary	Difference in diplopia score	Deterioration	Twelve months
Secondary	Difference in degrees of restriction	Improvement	Six months
Secondary	Difference in degrees of restriction	Improvement	Twelve months
Secondary	Difference in degrees of restriction	Deterioration	Six months
Secondary	Difference in degrees of restriction	Deterioration	Twelve months
Secondary	Difference in exophthalmos scores	Improvement	Six months
Secondary	Difference in exophthalmos scores	Improvement	Twelve months
Secondary	Difference in exophthalmos scores	Deterioration	Six months
Secondary	Difference in exophthalmos scores	Deterioration	Twelve months
Secondary	Difference in eyelid aperture	Improvement	Six months
Secondary	Difference in eyelid aperture	Improvement	Twelve months
Secondary	Difference in eyelid aperture	Deterioration	Six months
Secondary	Difference in eyelid aperture	Deterioration	Twelve months

External Links

•   This is the International Thyroid Eye Disease Society (ITEDS) website.