Oral Supplementation With Selenium in Patients With Mild Thyroid Orbitopathy

Sponsor

Instituto de Oftalmología Fundación Conde de Valenciana (Other)

Overall Status

Completed

CT.gov ID

NCT03891043

Collaborator

(none)

Enrollment

Arms

Actual Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Thyroid Orbitopathy	Dietary Supplement: Selenium Other: Placebo	N/A

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 Design

Study Type:

Interventional

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 :

Aug 1, 2015

Actual Primary Completion Date :

Apr 1, 2016

Actual Study Completion Date :

Apr 1, 2016

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Clinical Activity Score (CAS) [6 months after treatment]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Instituto de Oftalmología Fundación Conde de Valenciana

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Instituto de Oftalmología Fundación Conde de Valenciana

ClinicalTrials.gov Identifier:

NCT03891043

Other Study ID Numbers:

CI-043-2015

First Posted:

Mar 26, 2019

Last Update Posted:

Mar 26, 2019

Last Verified:

Sep 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Graves Ophthalmopathy

Thyroid Diseases

Selenium

Study Results

No Results Posted as of Mar 26, 2019