Oral Supplementation With Selenium in Patients With Mild Thyroid Orbitopathy
Keywords
Abstract
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.
Dates
| Last Verified: | 08/31/2018 |
| First Submitted: | 03/14/2019 |
| Estimated Enrollment Submitted: | 03/24/2019 |
| First Posted: | 03/25/2019 |
| Last Update Submitted: | 03/24/2019 |
| Last Update Posted: | 03/25/2019 |
| Actual Study Start Date: | 07/31/2015 |
| Estimated Primary Completion Date: | 03/31/2016 |
| Estimated Study Completion Date: | 03/31/2016 |
Condition or disease
Intervention/treatment
Dietary Supplement: Group B, Selenium group
Other: Group A, Placebo group
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Placebo Comparator: Group A, Placebo group Placebo consisted in a pill of 100 micrograms of starch, to be taken twice a day. | Other: Group A, Placebo group 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: Group B, Selenium group A 100 micrograms of Selenium was given to be taken twice a day. |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | 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 |
Outcome
Primary Outcome Measures
1. Clinical Activity Score (CAS) [6 months after treatment]
