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).
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).
Authors: Katie E Webster; Lisa O'Byrne; Samuel MacKeith; Carl Philpott; Claire Hopkins; Martin J Burton Journal: Cochrane Database Syst Rev Date: 2022-09-05
Authors: Lisa O'Byrne; Katie E Webster; Samuel MacKeith; Carl Philpott; Claire Hopkins; Martin J Burton Journal: Cochrane Database Syst Rev Date: 2022-09-05
Authors: Azita H Talasaz; Parham Sadeghipour; Maryam Aghakouchakzadeh; Isaac Dreyfus; Hessam Kakavand; Hamid Ariannejad; Aakriti Gupta; Mahesh V Madhavan; Benjamin W Van Tassell; David Jimenez; Manuel Monreal; Muthiah Vaduganathan; John Fanikos; Dave L Dixon; Gregory Piazza; Sahil A Parikh; Deepak L Bhatt; Gregory Y H Lip; Gregg W Stone; Harlan M Krumholz; Peter Libby; Samuel Z Goldhaber; Behnood Bikdeli Journal: J Am Coll Cardiol Date: 2021-10-19 Impact factor: 27.203
Authors: Annie E Allisan-Arrighi; Sarah K Rapoport; Benjamin M Laitman; Rohini Bahethi; Matthew Mori; Peak Woo; Eric Genden; Mark Courey; Diana N Kirke Journal: Laryngoscope Investig Otolaryngol Date: 2022-03-09
Authors: Katie E Webster; Lisa O'Byrne; Samuel MacKeith; Carl Philpott; Claire Hopkins; Martin J Burton Journal: Cochrane Database Syst Rev Date: 2021-07-22
Authors: Lisa O'Byrne; Katie E Webster; Samuel MacKeith; Carl Philpott; Claire Hopkins; Martin J Burton Journal: Cochrane Database Syst Rev Date: 2021-07-22