ClinicalTrials.Veeva

Menu

Oral Supplementation With Selenium in Patients With Mild Thyroid Orbitopathy

I

Instituto de Oftalmología Fundación Conde de Valenciana

Status

Completed

Conditions

Thyroid Orbitopathy

Treatments

Dietary Supplement: Selenium
Other: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT03891043
CI-043-2015

Details and patient eligibility

About

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.

Full 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.

Enrollment

33 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Double Blind

33 participants in 2 patient groups, including a placebo group

Group A, Placebo group
Placebo Comparator group
Description:
Placebo consisted in a pill of 100 micrograms of starch, to be taken twice a day.
Treatment:
Other: Placebo
Group B, Selenium group
Experimental group
Description:
Selenium consisted in a pill of 100 micrograms, to be taken twice a day.
Treatment:
Dietary Supplement: Selenium

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems