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Oral Supplementation With Selenium in Patients With Mild Thyroid Orbitopathy

Primary Purpose

Thyroid Orbitopathy

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Selenium
Placebo
Sponsored by
Instituto de Oftalmología Fundación Conde de Valenciana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid Orbitopathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    Group A, Placebo group

    Group B, Selenium group

    Arm Description

    Placebo consisted in a pill of 100 micrograms of starch, to be taken twice a day.

    Selenium consisted in a pill of 100 micrograms, to be taken twice a day.

    Outcomes

    Primary Outcome Measures

    Clinical Activity Score (CAS)
    Clinical Activity Score (CAS) scale consists of 7 measurements used to evaluate clinical activity of thyroid orbitopathy: Spontaneus orbital pain Gaze evoked orbital pain Conjunctival redness that is considered to be due to active GO Eyelid erythema Chemosis Eyelid swelling that is considered to be due to active GO Inflammation of plica or caruncle

    Secondary Outcome Measures

    Full Information

    First Posted
    March 15, 2019
    Last Updated
    March 25, 2019
    Sponsor
    Instituto de Oftalmología Fundación Conde de Valenciana
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03891043
    Brief Title
    Oral Supplementation With Selenium in Patients With Mild Thyroid Orbitopathy
    Official Title
    Oral Supplementation With Selenium in Patients With Mild Thyroid Orbitopathy to Reduce Its
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2015 (Actual)
    Primary Completion Date
    April 2016 (Actual)
    Study Completion Date
    April 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Instituto de Oftalmología Fundación Conde de Valenciana

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Thyroid Orbitopathy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    33 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A, Placebo group
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo consisted in a pill of 100 micrograms of starch, to be taken twice a day.
    Arm Title
    Group B, Selenium group
    Arm Type
    Experimental
    Arm Description
    Selenium consisted in a pill of 100 micrograms, to be taken twice a day.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Selenium
    Intervention Description
    A 100 micrograms of Selenium was given to be taken twice a day.
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo pill of 100 micrograms of starch was given to be taken twice a day.
    Primary Outcome Measure Information:
    Title
    Clinical Activity Score (CAS)
    Description
    Clinical Activity Score (CAS) scale consists of 7 measurements used to evaluate clinical activity of thyroid orbitopathy: Spontaneus orbital pain Gaze evoked orbital pain Conjunctival redness that is considered to be due to active GO Eyelid erythema Chemosis Eyelid swelling that is considered to be due to active GO Inflammation of plica or caruncle
    Time Frame
    6 months after treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Learn more about this trial

    Oral Supplementation With Selenium in Patients With Mild Thyroid Orbitopathy

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