Oral Supplementation With Selenium in Patients With Mild Thyroid Orbitopathy

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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Key information

Conditions

Thyroid Orbitopathy Autoimmune Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Endocrine System Diseases Exophthalmos Eye Diseases Eye Diseases, Hereditary Genetic Diseases, Inborn Goiter Graves Disease Graves Ophthalmopathy Hyperthyroidism Immune System Diseases Orbital Diseases Thyroid Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Selenium

Dietary Supplement

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

Placebo

Other

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

Primary outcomes

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:
- 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

Sponsors and collaborators

Lead sponsor

Instituto de Oftalmología Fundación Conde de Valenciana

Other

Registry information

Official study title

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

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Mar 26, 2019
Registry last updated: Mar 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed