Oral Supplementation With Selenium in Patients With Mild Thyroid Orbitopathy
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|ClinicalTrials.gov Identifier: NCT03891043|
Recruitment Status : Completed
First Posted : March 26, 2019
Last Update Posted : March 26, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Thyroid Orbitopathy||Dietary Supplement: Selenium Other: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Oral Supplementation With Selenium in Patients With Mild Thyroid Orbitopathy to Reduce Its|
|Actual Study Start Date :||August 2015|
|Actual Primary Completion Date :||April 2016|
|Actual Study Completion Date :||April 2016|
Placebo Comparator: Group A, Placebo group
Placebo consisted in a pill of 100 micrograms of starch, to be taken twice a day.
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: Selenium
A 100 micrograms of Selenium was given to be taken twice a day.
- 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
- Eyelid swelling that is considered to be due to active GO
- Inflammation of plica or caruncle