Selenium in Mild Thyroid Eye Disease in North America (S-ITEDS)

Selenium - ITEDS: A North American Study

The purpose of this study is to determine whether sodium selenite is helpful in the treatment of mild thyroid eye disease in North America.

Study Overview

• Status: Withdrawn
• Conditions: Thyroid Associated Ophthalmopathies
• Intervention / Treatment: Drug: Sodium selenate; Dietary supplement: Sugar pill

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.

• Study Type: Interventional
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Time Frame
Fasting glucose level	Six months

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: International Thyroid Eye Disease Society
• Investigators: Principal Investigator: Micahel Kazim, MD, International Thyroid Eye Disease Society

Publications and helpful links

General Publications

• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2015
• Primary Completion (Actual): November 16, 2016
• Study Completion (Actual): November 16, 2016

Study Registration Dates

• First Submitted: April 8, 2014
• First Submitted That Met QC Criteria: April 10, 2014
• First Posted (Estimate): April 14, 2014

Study Record Updates

• Last Update Posted (Actual): August 18, 2021
• Last Update Submitted That Met QC Criteria: August 12, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Thyroid eye disease; Graves' orbitopathy; Graves' ophthalmopathy; Thyroid orbitopathy
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Genetic Diseases, Inborn; Eye Diseases, Hereditary; Graves Disease; Exophthalmos; Orbital Diseases; Goiter; Hyperthyroidism; Eye Diseases; Graves Ophthalmopathy; Thyroid Diseases; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Trace Elements; Micronutrients; Antioxidants; Selenium; Selenic Acid
• Other Study ID Numbers: AAAL9502

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No