NCT02112643

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2015

Shorter than P25 for phase_3

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 8, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 14, 2014

Completed
1.5 years until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 16, 2016

Completed
Last Updated

August 18, 2021

Status Verified

August 1, 2021

Enrollment Period

1.1 years

First QC Date

April 8, 2014

Last Update Submit

August 12, 2021

Conditions

Thyroid Associated Ophthalmopathies

Keywords

Thyroid eye diseaseThyroid orbitopathyGraves' orbitopathyGraves' ophthalmopathy

Outcome Measures

Primary Outcomes (4)

  • Difference in Quality of Life score

    Using GO-QOL score

    Six months

  • Difference in Quality of Life score

    GO-QOL score

    Twelve months

  • Change in Thyroid Eye Disease

    Six months

  • Change in Thyroid Eye Disease

    Twelve months

Secondary Outcomes (27)

  • Difference in Clinical Activity Score

    Six months

  • Difference in Clinical Activity Score

    Twelve months

  • Difference in Quality of Life score

    Six months

  • Difference in Quality of Life score

    Twelve months

  • Difference in Quality of Life score

    Six months

  • +22 more secondary outcomes

Other Outcomes (1)

  • Fasting glucose level

    Six months

Study Arms (2)

Selenium

ACTIVE COMPARATOR

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

Drug: Sodium selenate

Sugar pill

PLACEBO COMPARATOR

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

Dietary Supplement: Sugar pill

Interventions

Sodium selenateDRUG

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

Also known as: Selenium
Selenium
Sugar pillDIETARY_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.

Also known as: Placebo
Sugar pill

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 21591944BACKGROUND

Related Links

MeSH Terms

Conditions

Graves Ophthalmopathy

Interventions

Selenic AcidSeleniumSugars

Condition Hierarchy (Ancestors)

Eye Diseases, HereditaryEye DiseasesGraves DiseaseExophthalmosOrbital DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGoiterThyroid DiseasesEndocrine System DiseasesHyperthyroidismAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Selenium CompoundsInorganic ChemicalsChalcogensElementsMineralsCarbohydrates

Study Officials

  • Micahel Kazim, MD

    International Thyroid Eye Disease Society

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2014

First Posted

April 14, 2014

Study Start

October 1, 2015

Primary Completion

November 16, 2016

Study Completion

November 16, 2016

Last Updated

August 18, 2021

Record last verified: 2021-08