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Oral Supplementation With Selenium in Patients With Mild Thyroid Orbitopathy

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Instituto de Oftalmología Fundación Conde de Valenciana

Sleutelwoorden

Abstract

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.

Omschrijving

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.

Datums

Laatst geverifieerd: 08/31/2018
Eerste ingediend: 03/14/2019
Geschatte inschrijving ingediend: 03/24/2019
Eerst geplaatst: 03/25/2019
Laatste update ingediend: 03/24/2019
Laatste update geplaatst: 03/25/2019
Werkelijke startdatum van het onderzoek: 07/31/2015
Geschatte primaire voltooiingsdatum: 03/31/2016
Geschatte voltooiingsdatum van het onderzoek: 03/31/2016

Conditie of ziekte

Thyroid Orbitopathy

Interventie / behandeling

Dietary Supplement: Group B, Selenium group

Other: Group A, Placebo group

Fase

-

Armgroepen

ArmInterventie / behandeling
Placebo Comparator: Group A, Placebo group
Placebo consisted in a pill of 100 micrograms of starch, to be taken twice a day.
Other: Group A, Placebo group
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: Group B, Selenium group
A 100 micrograms of Selenium was given to be taken twice a day.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie 18 Years Naar 18 Years
Geslachten die in aanmerking komen voor studieAll
Accepteert gezonde vrijwilligersJa
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

Resultaat

Primaire uitkomstmaten

1. 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

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