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Oral Supplementation With Selenium in Patients With Mild Thyroid Orbitopathy

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. Identifier: NCT03891043
Recruitment Status : Completed
First Posted : March 26, 2019
Last Update Posted : March 26, 2019
Information provided by (Responsible Party):
Instituto de Oftalmología Fundación Conde de Valenciana

Brief Summary:

Background: The activity of thyroid orbitopathy can be evaluated with CAS (Clinical Activity Score) based on 7 inflammatory signs. Selenium acts as an oxide-reducing agent in thioredoxin-reductase, and as an anti-inflammatory agent by reducing the hydroxy peroxide intermediates on the cyclo-oxygenase pathways. Increased oxidative stress has been observed in Graves' disease and therefore, by incorporating an antioxidant such as selenium in patients with mild thyroid ophthalmopathy, inflammatory activity could be reduced or inactivated.

General Objective: To determine the clinical differences between patients with mild thyroid orbitopathy who were administered oral supplementation with selenium and patients who were administered oral placebo.

Condition or disease Intervention/treatment Phase
Thyroid Orbitopathy Dietary Supplement: Selenium Other: Placebo Not Applicable

Detailed Description:
This is a simple controlled clinical trial. In which 66 eyes of 33 patients were studied. Fifteen patients were assigned to the placebo group and 18 to the Selenium group. We randomized into two groups the patients with mild clinical activity according to CAS score. Group A took placebo pills twice a day which consisted in 100µg of starch, and Group B took a pill of Selenium 100 µg twice a day. All the subjects tool the pills during six months. Patients of both groups where examined and evaluated with CAS score before and after the first, third and sixth month of treatment.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Oral Supplementation With Selenium in Patients With Mild Thyroid Orbitopathy to Reduce Its
Actual Study Start Date : August 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thyroid Diseases

Arm Intervention/treatment
Placebo Comparator: Group A, Placebo group
Placebo consisted in a pill of 100 micrograms of starch, to be taken twice a day.
Other: Placebo
Placebo pill of 100 micrograms of starch was given to be taken twice a day.

Experimental: Group B, Selenium group
Selenium consisted in a pill of 100 micrograms, to be taken twice a day.
Dietary Supplement: Selenium
A 100 micrograms of Selenium was given to be taken twice a day.

Primary Outcome Measures :
  1. Clinical Activity Score (CAS) [ Time Frame: 6 months after treatment ]

    Clinical Activity Score (CAS) scale consists of 7 measurements used to evaluate clinical activity of thyroid orbitopathy:

    1. Spontaneus orbital pain
    2. Gaze evoked orbital pain
    3. Conjunctival redness that is considered to be due to active GO
    4. Eyelid erythema
    5. Chemosis
    6. Eyelid swelling that is considered to be due to active GO
    7. Inflammation of plica or caruncle

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

Inclusion Criteria:

  • Patients with active mild thyroid orbitopathy according to CAS scale.
  • Older than 18 years of age.

Exclusion Criteria:

  • Patients with mild thyroid orbitopathy undergoing treatment with corticosteroids.
  • Active smokers
  • Patients allergic to Selenium
  • Follow-up shorter than 6 months
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Responsible Party: Instituto de Oftalmología Fundación Conde de Valenciana Identifier: NCT03891043    
Other Study ID Numbers: CI-043-2015
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Graves Ophthalmopathy
Thyroid Diseases
Endocrine System Diseases
Eye Diseases, Hereditary
Eye Diseases
Graves Disease
Orbital Diseases
Genetic Diseases, Inborn
Autoimmune Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Trace Elements
Growth Substances