Oral Supplementation With Selenium in Patients With Mild Thyroid Orbitopathy

March 25, 2019 updated by: Instituto de Oftalmología Fundación Conde de Valenciana

Oral Supplementation With Selenium in Patients With Mild Thyroid Orbitopathy to Reduce Its

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Oftalmología Fundación Conde de Valenciana

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2015

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

March 15, 2019

First Submitted That Met QC Criteria

March 25, 2019

First Posted (Actual)

March 26, 2019

Study Record Updates

Last Update Posted (Actual)

March 26, 2019

Last Update Submitted That Met QC Criteria

March 25, 2019

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CI-043-2015

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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