- Open Access
Letter to the editor: Study Summary - Randomized Control Trial of Omega-3 Fatty Acid Supplementation for the Treatment of COVID-19 Related Olfactory Dysfunction
Trials volume 21, Article number: 942 (2020)
To evaluate a therapeutic role for omega-3 fatty acid supplementation in the treatment of olfactory dysfunction associated with COVID-19 infection
Randomized, double-blinded, placebo-controlled trial
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.
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.
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.
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.
Protocol Version 1, 8/3/2020
Recruitment is ongoing, started 8/5/2020 with estimated completion 11/30/2020.
The trial is registered on ClinicalTrials.gov with Protocol Identifier: NCT04495816.
Trial registration: ClinicalTrials.gov, NCT04495816. Registered 3 August 2020
The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1).
Availability of data and materials
The final trial dataset will be accessible from the author on reasonable request. Contact David Lerner (e-mail email@example.com).
No funding was received for this study. Study drug and capsules were provided by Pharmavite®. Pharmavite® had no role in the design of the study and collection, analysis and interpretation of data and in the writing of the manuscript.
Ethics approval and consent to participate
This study protocol was approved by the Institutional Review Board at the Icahn School of Medicine at Mount Sinai on 7/10/2020 (HS#:20-00511, GCO#20-1132 ISMMS).
Informed consent will be obtained from all participants. Only adults are included in the study.
Consent for publication
The authors declare that they have no competing interests.
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
About this article
Cite this article
Lerner, D., Garvey, K., Arrighi-Allisan, A. et al. Letter to the editor: Study Summary - Randomized Control Trial of Omega-3 Fatty Acid Supplementation for the Treatment of COVID-19 Related Olfactory Dysfunction. Trials 21, 942 (2020). https://doi.org/10.1186/s13063-020-04905-y
- Randomised controlled trial
- olfactory dysfunction
- omega-3 fatty acid
- smell loss