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Withdrawn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
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
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
NCT ID
NCT02112643
First Posted
April 8, 2014
Last Updated
August 12, 2021
Sponsor
Columbia University
Collaborators
International Thyroid Eye Disease Society
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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