Oral Supplementation With Selenium in Patients With Mild Thyroid Orbitopathy

Thyroid Orbitopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03891043
• Other study ID #: CI-043-2015
• Status: Completed
• Phase: N/A
• Start date: August 2015
• Est. completion date: April 2016

Study information

• Verified date: September 2018
• Source: Instituto de Oftalmología Fundación Conde de Valenciana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Graves Ophthalmopathy
• Thyroid Diseases
• Thyroid Orbitopathy

Intervention

Dietary Supplement:
• Selenium
A 100 micrograms of Selenium was given to be taken twice a day.

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Oftalmología Fundación Conde de Valenciana

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Activity Score (CAS)	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	6 months after treatment