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

Primary Purpose

Thyroid Associated Ophthalmopathies

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Sodium selenate
Sugar pill
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid Associated Ophthalmopathies focused on measuring Thyroid eye disease, Thyroid orbitopathy, Graves' orbitopathy, Graves' ophthalmopathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Selenium

    Sugar pill

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Difference in Quality of Life score
    Using GO-QOL score
    Difference in Quality of Life score
    GO-QOL score
    Change in Thyroid Eye Disease
    Change in Thyroid Eye Disease

    Secondary Outcome Measures

    Difference in Clinical Activity Score
    Difference in Clinical Activity Score
    Difference in Quality of Life score
    TED-PRO
    Difference in Quality of Life score
    TED-PRO
    Difference in Quality of Life score
    TED-QOL
    Difference in Quality of Life score
    TED-QOL
    Difference in development of optic neuropathy
    Difference in Inflammatory Index
    Improvement
    Difference in Inflammatory Index
    Improvement
    Difference in Inflammatory Index
    Deterioration
    Difference in Inflammatory Index
    Deterioration
    Difference in diplopia score
    Improvement
    Difference in diplopia score
    Improvement
    Difference in diplopia score
    Deterioration
    Difference in diplopia score
    Deterioration
    Difference in degrees of restriction
    Improvement
    Difference in degrees of restriction
    Improvement
    Difference in degrees of restriction
    Deterioration
    Difference in degrees of restriction
    Deterioration
    Difference in exophthalmos scores
    Improvement
    Difference in exophthalmos scores
    Improvement
    Difference in exophthalmos scores
    Deterioration
    Difference in exophthalmos scores
    Deterioration
    Difference in eyelid aperture
    Improvement
    Difference in eyelid aperture
    Improvement
    Difference in eyelid aperture
    Deterioration
    Difference in eyelid aperture
    Deterioration

    Full Information

    First Posted
    April 8, 2014
    Last Updated
    August 12, 2021
    Sponsor
    Columbia University
    Collaborators
    International Thyroid Eye Disease Society
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02112643
    Brief Title
    Selenium in Mild Thyroid Eye Disease in North America
    Acronym
    S-ITEDS
    Official Title
    Selenium - ITEDS: A North American Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Lack of funding
    Study Start Date
    October 2015 (Anticipated)
    Primary Completion Date
    November 16, 2016 (Actual)
    Study Completion Date
    November 16, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Columbia University
    Collaborators
    International Thyroid Eye Disease Society

    4. Oversight

    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
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Thyroid Associated Ophthalmopathies
    Keywords
    Thyroid eye disease, Thyroid orbitopathy, Graves' orbitopathy, Graves' ophthalmopathy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Selenium
    Arm Type
    Active Comparator
    Arm Description
    100 micrograms of sodium selenate will be taken orally twice daily (total 200 micrograms daily) for 6 months.
    Arm Title
    Sugar pill
    Arm Type
    Placebo Comparator
    Arm Description
    A placebo pill will be taken orally twice daily for 6 months.
    Intervention Type
    Drug
    Intervention Name(s)
    Sodium selenate
    Other Intervention Name(s)
    Selenium
    Intervention Description
    A 100 microgram pill will be orally administered twice a day for 6 months.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Sugar pill
    Other Intervention Name(s)
    Placebo
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Difference in Quality of Life score
    Description
    Using GO-QOL score
    Time Frame
    Six months
    Title
    Difference in Quality of Life score
    Description
    GO-QOL score
    Time Frame
    Twelve months
    Title
    Change in Thyroid Eye Disease
    Time Frame
    Six months
    Title
    Change in Thyroid Eye Disease
    Time Frame
    Twelve months
    Secondary Outcome Measure Information:
    Title
    Difference in Clinical Activity Score
    Time Frame
    Six months
    Title
    Difference in Clinical Activity Score
    Time Frame
    Twelve months
    Title
    Difference in Quality of Life score
    Description
    TED-PRO
    Time Frame
    Six months
    Title
    Difference in Quality of Life score
    Description
    TED-PRO
    Time Frame
    Twelve months
    Title
    Difference in Quality of Life score
    Description
    TED-QOL
    Time Frame
    Six months
    Title
    Difference in Quality of Life score
    Description
    TED-QOL
    Time Frame
    Twelve months
    Title
    Difference in development of optic neuropathy
    Time Frame
    Twelve months
    Title
    Difference in Inflammatory Index
    Description
    Improvement
    Time Frame
    Six months
    Title
    Difference in Inflammatory Index
    Description
    Improvement
    Time Frame
    Twelve months
    Title
    Difference in Inflammatory Index
    Description
    Deterioration
    Time Frame
    Six months
    Title
    Difference in Inflammatory Index
    Description
    Deterioration
    Time Frame
    Twelve months
    Title
    Difference in diplopia score
    Description
    Improvement
    Time Frame
    Six months
    Title
    Difference in diplopia score
    Description
    Improvement
    Time Frame
    Twelve months
    Title
    Difference in diplopia score
    Description
    Deterioration
    Time Frame
    Six months
    Title
    Difference in diplopia score
    Description
    Deterioration
    Time Frame
    Twelve months
    Title
    Difference in degrees of restriction
    Description
    Improvement
    Time Frame
    Six months
    Title
    Difference in degrees of restriction
    Description
    Improvement
    Time Frame
    Twelve months
    Title
    Difference in degrees of restriction
    Description
    Deterioration
    Time Frame
    Six months
    Title
    Difference in degrees of restriction
    Description
    Deterioration
    Time Frame
    Twelve months
    Title
    Difference in exophthalmos scores
    Description
    Improvement
    Time Frame
    Six months
    Title
    Difference in exophthalmos scores
    Description
    Improvement
    Time Frame
    Twelve months
    Title
    Difference in exophthalmos scores
    Description
    Deterioration
    Time Frame
    Six months
    Title
    Difference in exophthalmos scores
    Description
    Deterioration
    Time Frame
    Twelve months
    Title
    Difference in eyelid aperture
    Description
    Improvement
    Time Frame
    Six months
    Title
    Difference in eyelid aperture
    Description
    Improvement
    Time Frame
    Twelve months
    Title
    Difference in eyelid aperture
    Description
    Deterioration
    Time Frame
    Six months
    Title
    Difference in eyelid aperture
    Description
    Deterioration
    Time Frame
    Twelve months
    Other Pre-specified Outcome Measures:
    Title
    Fasting glucose level
    Time Frame
    Six months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Micahel Kazim, MD
    Organizational Affiliation
    International Thyroid Eye Disease Society
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    21591944
    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.
    Results Reference
    background
    Links:
    URL
    http://thyroideyedisease.org/
    Description
    This is the International Thyroid Eye Disease Society (ITEDS) website.

    Learn more about this trial

    Selenium in Mild Thyroid Eye Disease in North America

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