Letter to the editor: Study Summary - Randomized Control Trial of Omega-3 Fatty Acid Supplementation for the Treatment of COVID-19 Related Olfactory Dysfunction
David Lerner, Katherine Garvey, Annie Arrighi-Allisan, Andrey Filimonov, Peter Filip, Katherine Liu, Sen Ninan, Madeleine Schaberg, Patrick Colley, Anthony Del Signore, Satish Govindaraj, Alfred Marc Iloreta, David Lerner, Katherine Garvey, Annie Arrighi-Allisan, Andrey Filimonov, Peter Filip, Katherine Liu, Sen Ninan, Madeleine Schaberg, Patrick Colley, Anthony Del Signore, Satish Govindaraj, Alfred Marc Iloreta
Abstract
Objectives: To evaluate a therapeutic role for omega-3 fatty acid supplementation in the treatment of olfactory dysfunction associated with COVID-19 infection TRIAL DESIGN: Randomized, double-blinded, placebo-controlled trial PARTICIPANTS: Eligible patients are adults with self-reported new-onset olfactory dysfunction of any duration associated with laboratory-confirmed or clinically suspected COVID-19 patients. Exclusion criteria include patients with pre-existing olfactory dysfunction, history of chronic rhinosinusitis or history of sinus surgery, current use of nasal steroid sprays or omega-3 supplementation, fish allergy, or inability to provide informed consent for any reason. The trial is conducted at Mount Sinai Hospital INTERVENTION AND COMPARATOR: The intervention group will receive 2000 mg daily of omega-3 supplementation in the form of two "Fish Oil, Ultra Omega-3" capsules (product of Pharmavite®) daily. The comparator group will take 2 placebo capsules of identical size, shape, and odor daily for 6 weeks.
Main outcomes: Each subject will take a Brief Smell Identification Test at study enrolment and completion after 6 weeks. The primary outcome will be change in Brief Smell Identification Test over the 6-week period.
Randomisation: Patients will be randomized by the Investigational Drug Pharmacy at the Icahn School of Medicine at Sinai via a computer-generated sequence in a 1:1 allocation to treatment or control arms.
Blinding (masking): Both participants and researchers will be blinded.
Numbers to be randomised (sample size): There will be 88 participants randomized to each group. A total of 176 participants will be randomized.
Trial status: Protocol Version 1, 8/3/2020 Recruitment is ongoing, started 8/5/2020 with estimated completion 11/30/2020.
Trial registration: The trial is registered on ClinicalTrials.gov with Protocol Identifier: NCT04495816 .
Trial registration: ClinicalTrials.gov, NCT04495816 . Registered 3 August 2020 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1).
Keywords: COVID-19; Randomised controlled trial; olfactory dysfunction; omega-3 fatty acid; protocol; smell loss.
Conflict of interest statement
The authors declare that they have no competing interests.
Source: PubMed