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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02112643
Recruitment Status : Withdrawn (Lack of funding)
First Posted : April 14, 2014
Last Update Posted : August 18, 2021
Sponsor:
Collaborator:
International Thyroid Eye Disease Society
Information provided by (Responsible Party):
Columbia University

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.

Condition or disease Intervention/treatment Phase
Thyroid Associated Ophthalmopathies Drug: Sodium selenate Dietary Supplement: Sugar pill Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Selenium - ITEDS: A North American Study
Estimated Study Start Date : October 2015
Actual Primary Completion Date : November 16, 2016
Actual Study Completion Date : November 16, 2016

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Placebo




Primary Outcome Measures :
  1. Difference in Quality of Life score [ Time Frame: Six months ]
    Using GO-QOL score

  2. Difference in Quality of Life score [ Time Frame: Twelve months ]
    GO-QOL score

  3. Change in Thyroid Eye Disease [ Time Frame: Six months ]
  4. Change in Thyroid Eye Disease [ Time Frame: Twelve months ]

Secondary Outcome Measures :
  1. Difference in Clinical Activity Score [ Time Frame: Six months ]
  2. Difference in Clinical Activity Score [ Time Frame: Twelve months ]
  3. Difference in Quality of Life score [ Time Frame: Six months ]
    TED-PRO

  4. Difference in Quality of Life score [ Time Frame: Twelve months ]
    TED-PRO

  5. Difference in Quality of Life score [ Time Frame: Six months ]
    TED-QOL

  6. Difference in Quality of Life score [ Time Frame: Twelve months ]
    TED-QOL

  7. Difference in development of optic neuropathy [ Time Frame: Twelve months ]
  8. Difference in Inflammatory Index [ Time Frame: Six months ]
    Improvement

  9. Difference in Inflammatory Index [ Time Frame: Twelve months ]
    Improvement

  10. Difference in Inflammatory Index [ Time Frame: Six months ]
    Deterioration

  11. Difference in Inflammatory Index [ Time Frame: Twelve months ]
    Deterioration

  12. Difference in diplopia score [ Time Frame: Six months ]
    Improvement

  13. Difference in diplopia score [ Time Frame: Twelve months ]
    Improvement

  14. Difference in diplopia score [ Time Frame: Six months ]
    Deterioration

  15. Difference in diplopia score [ Time Frame: Twelve months ]
    Deterioration

  16. Difference in degrees of restriction [ Time Frame: Six months ]
    Improvement

  17. Difference in degrees of restriction [ Time Frame: Twelve months ]
    Improvement

  18. Difference in degrees of restriction [ Time Frame: Six months ]
    Deterioration

  19. Difference in degrees of restriction [ Time Frame: Twelve months ]
    Deterioration

  20. Difference in exophthalmos scores [ Time Frame: Six months ]
    Improvement

  21. Difference in exophthalmos scores [ Time Frame: Twelve months ]
    Improvement

  22. Difference in exophthalmos scores [ Time Frame: Six months ]
    Deterioration

  23. Difference in exophthalmos scores [ Time Frame: Twelve months ]
    Deterioration

  24. Difference in eyelid aperture [ Time Frame: Six months ]
    Improvement

  25. Difference in eyelid aperture [ Time Frame: Twelve months ]
    Improvement

  26. Difference in eyelid aperture [ Time Frame: Six months ]
    Deterioration

  27. Difference in eyelid aperture [ Time Frame: Twelve months ]
    Deterioration


Other Outcome Measures:
  1. Fasting glucose level [ Time Frame: Six months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02112643


Sponsors and Collaborators
Columbia University
International Thyroid Eye Disease Society
Investigators
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Principal Investigator: Micahel Kazim, MD International Thyroid Eye Disease Society
Additional Information:
Publications:
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Responsible Party: Columbia University
ClinicalTrials.gov Identifier: NCT02112643    
Other Study ID Numbers: AAAL9502
First Posted: April 14, 2014    Key Record Dates
Last Update Posted: August 18, 2021
Last Verified: August 2021

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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
Keywords provided by Columbia University:
Thyroid eye disease
Thyroid orbitopathy
Graves' orbitopathy
Graves' ophthalmopathy
Additional relevant MeSH terms:
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Eye Diseases
Graves Ophthalmopathy
Thyroid Diseases
Endocrine System Diseases
Eye Diseases, Hereditary
Graves Disease
Exophthalmos
Orbital Diseases
Genetic Diseases, Inborn
Goiter
Hyperthyroidism
Autoimmune Diseases
Immune System Diseases
Selenium
Selenic Acid
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Trace Elements
Micronutrients