TY - JOUR
T1 - Letter to the editor
T2 - Study Summary - Randomized Control Trial of Omega-3 Fatty Acid Supplementation for the Treatment of COVID-19 Related Olfactory Dysfunction
AU - Lerner, David
AU - Garvey, Katherine
AU - Arrighi-Allisan, Annie
AU - Filimonov, Andrey
AU - Filip, Peter
AU - Liu, Katherine
AU - Ninan, Sen
AU - Schaberg, Madeleine
AU - Colley, Patrick
AU - Del Signore, Anthony
AU - Govindaraj, Satish
AU - Iloreta, Alfred Marc
N1 - Publisher Copyright:
© 2020, The Author(s).
PY - 2020/12
Y1 - 2020/12
N2 - 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).
AB - 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).
KW - COVID-19
KW - Randomised controlled trial
KW - olfactory dysfunction
KW - omega-3 fatty acid
KW - protocol
KW - smell loss
UR - http://www.scopus.com/inward/record.url?scp=85096386390&partnerID=8YFLogxK
U2 - 10.1186/s13063-020-04905-y
DO - 10.1186/s13063-020-04905-y
M3 - Letter
C2 - 33225989
AN - SCOPUS:85096386390
SN - 1745-6215
VL - 21
JO - Trials
JF - Trials
IS - 1
M1 - 942
ER -