Oral Supplementation With Selenium in Patients With Mild Thyroid Orbitopathy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2016-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Thyroid Orbitopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Group A, Placebo group

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo pill of 100 micrograms of starch was given to be taken twice a day.

Group B, Selenium group

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

Group Type EXPERIMENTAL

Selenium

Intervention Type DIETARY_SUPPLEMENT

A 100 micrograms of Selenium was given to be taken twice a day.

Interventions

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Selenium

A 100 micrograms of Selenium was given to be taken twice a day.

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo pill of 100 micrograms of starch was given to be taken twice a day.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No