Oral Supplementation With Selenium in Patients With Mild Thyroid Orbitopathy

Not Applicable

Completed

• Conditions: Thyroid Orbitopathy
• Interventions: Dietary Supplement: Selenium; Other: Placebo

• Registration Number: NCT03891043
• Lead Sponsor: Instituto de Oftalmología Fundación Conde de Valenciana

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.

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 Timeline

• Study Start: 2015-08
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2018-09
• Study First Submitted: 2019-03-15
• Study First Submitted QC: 2019-03-25
• Last Update Submitted: 2019-03-25
• Study First Posted: 2019-03-26
• Last Update Posted: 2019-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Group B, Selenium group	Selenium	Selenium consisted in a pill of 100 micrograms, to be taken twice a day.
Group A, Placebo group	Placebo	Placebo consisted in a pill of 100 micrograms of starch, to be taken twice a day.

Primary Outcome Measures

Name	Time	Method
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: 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