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Thyroid Associated OphthalmopathiesPhase 3S-ITEDSNCT02112643

Selenium in Mild Thyroid Eye Disease in North America

A Phase 3 study testing Sodium selenate and Sugar pill in people with Thyroid Associated Ophthalmopathies, run by Columbia University.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Thyroid Associated Ophthalmopathies
What is being tested?
Sodium selenate and Sugar pill
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
No sites listed yet
Study dates
Oct 2015to 16 Nov 2016
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

About this study

Official title: 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.

Read the 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.

Being tested
Sodium selenate, Sugar pill
Keywords
Thyroid eye disease, Thyroid orbitopathy, Graves' orbitopathy, Graves' ophthalmopathy
Medical subject headings
Graves Ophthalmopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sodium selenateDrug

    Also called Selenium

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

  • Sugar pillDietary supplement

    Also called Placebo

    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.

Study groups in NCT02112643
Study groupRoleWhat they receive
SeleniumActive comparator100 micrograms of sodium selenate will be taken orally twice daily (total 200 micrograms daily) for 6 months.
Receives: Drug: Sodium selenate
Sugar pillPlacebo comparatorA placebo pill will be taken orally twice daily for 6 months.
Receives: Dietary Supplement: Sugar pill

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Difference in Quality of Life score

    Using GO-QOL score

    Measured: Six months

  2. Difference in Quality of Life score

    GO-QOL score

    Measured: Twelve months

  3. Change in Thyroid Eye Disease

    Measured: Six months

  4. Change in Thyroid Eye Disease

    Measured: Twelve months

Secondary outcomes (27)

  1. Difference in Clinical Activity Score

    Measured: Six months

  2. Difference in Clinical Activity Score

    Measured: Twelve months

  3. Difference in Quality of Life score

    TED-PRO

    Measured: Six months

  4. Difference in Quality of Life score

    TED-PRO

    Measured: Twelve months

  5. Difference in Quality of Life score

    TED-QOL

    Measured: Six months

  6. Difference in Quality of Life score

    TED-QOL

    Measured: Twelve months

  7. Difference in development of optic neuropathy

    Measured: Twelve months

  8. Difference in Inflammatory Index

    Improvement

    Measured: Six months

  9. Difference in Inflammatory Index

    Improvement

    Measured: Twelve months

  10. Difference in Inflammatory Index

    Deterioration

    Measured: Six months

  11. Difference in Inflammatory Index

    Deterioration

    Measured: Twelve months

  12. Difference in diplopia score

    Improvement

    Measured: Six months

  13. Difference in diplopia score

    Improvement

    Measured: Twelve months

  14. Difference in diplopia score

    Deterioration

    Measured: Six months

  15. Difference in diplopia score

    Deterioration

    Measured: Twelve months

  16. Difference in degrees of restriction

    Improvement

    Measured: Six months

  17. Difference in degrees of restriction

    Improvement

    Measured: Twelve months

  18. Difference in degrees of restriction

    Deterioration

    Measured: Six months

  19. Difference in degrees of restriction

    Deterioration

    Measured: Twelve months

  20. Difference in exophthalmos scores

    Improvement

    Measured: Six months

  21. Difference in exophthalmos scores

    Improvement

    Measured: Twelve months

  22. Difference in exophthalmos scores

    Deterioration

    Measured: Six months

  23. Difference in exophthalmos scores

    Deterioration

    Measured: Twelve months

  24. Difference in eyelid aperture

    Improvement

    Measured: Six months

  25. Difference in eyelid aperture

    Improvement

    Measured: Twelve months

  26. Difference in eyelid aperture

    Deterioration

    Measured: Six months

  27. Difference in eyelid aperture

    Deterioration

    Measured: Twelve months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2014 (estimated)
  2. Study startOct 2015 (estimated)
  3. Primary completion16 Nov 2016
  4. Study completion16 Nov 2016

Why it stopped: Lack of funding

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02112643
Sponsor's protocol ID
AAAL9502
Acronym
S-ITEDS
Status last verified
Aug 2021
First submitted
8 Apr 2014
Last updated
18 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

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.

    PubMed 21591944

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sodium selenate and Sugar pill in people with Thyroid Associated Ophthalmopathies, run by Columbia University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 18 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in Quality of Life score (time frame: Six months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02112643, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2021.

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