Selenium in Mild Thyroid Eye Disease in North America

NCT ID: NCT02112643

Last Updated: 2021-08-18

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2016-11-16

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.

Conditions

Thyroid Associated Ophthalmopathies

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Selenium

100 micrograms of sodium selenate will be taken orally twice daily (total 200 micrograms daily) for 6 months.

Group Type: ACTIVE_COMPARATOR

Sodium selenate

Intervention Type: DRUG

A 100 microgram pill will be orally administered twice a day for 6 months.

Sugar pill

A placebo pill will be taken orally twice daily for 6 months.

Group Type: PLACEBO_COMPARATOR

Sugar pill

Intervention Type: 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.

Interventions

Sodium selenate

A 100 microgram pill will be orally administered twice a day for 6 months.

Intervention Type: DRUG

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.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Selenium; Placebo

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

International Thyroid Eye Disease Society

UNKNOWN

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Micahel Kazim, MD

Role: PRINCIPAL_INVESTIGATOR

International Thyroid Eye Disease Society

References

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.

Reference Type: BACKGROUND

PMID: 21591944 (View on PubMed)

Related Links

http://thyroideyedisease.org/

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

Other Identifiers

AAAL9502

Identifier Type: -

Identifier Source: org_study_id