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
About this trial
This is an interventional treatment trial for Thyroid Orbitopathy
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
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
NCT ID
NCT03891043
First Posted
March 15, 2019
Last Updated
March 25, 2019
Sponsor
Instituto de Oftalmología Fundación Conde de Valenciana
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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