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COVID-19Phase 1NCT05121766

Feasibility Pilot Clinical Trial of Omega-3 Supplement vs. Placebo for Post Covid-19 Recovery Among Health Care Workers

A Phase 1 study testing Omega-3 (EPA+DHA) in people with COVID-19, run by Hackensack Meridian Health at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a two-arm, double blind randomized 12-week study to supplement omega-3 (Eicosapentaenoic acid - EPA + docosahexaenoic acid - DHA) among 100 adults (age 18+) who had coronavirus-19 (covid-19) and are experiencing possible after-effects from post-acute sequelae of covid-19 (also called post-covid syndrome or… Read more about this study

Who is it for?
Ages 18 to 89 yearsHealthy volunteers can take part
Conditions the study is for
COVID-19
What is being tested?
Omega-3 (EPA+DHA)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
32 participants
Where
1 siteUnited States
Study dates
10 Jan 2022to 21 Apr 2023
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 89 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Team member at Hackensack Meridian Health
  • Age: 18+
  • Willing to provide informed consent
  • Formal diagnosis of COVID-19 via Polymerase Chain Reaction (PCR)test (if home test was done, team member must confirm via PCR test)
  • Outpatient treatment only for covid-19; no hospitalization (most team members will be vaccinated and may likely have milder case)
  • Must be experiencing 1+ ongoing covid-19 symptom being measured in this study (respiratory symptoms (shortness of breath, cough), fatigue, loss of taste, loss of smell)
Show all 16Show fewer
  • Symptom(s) have persisted for more than 12 weeks after initial infection
  • Symptom(s) coincided with covid-19 infection and were not present prior to covid-19 infection
  • Does not have soy allergy
  • Does not have allergy to fish
  • Able to participate in bi-weekly surveys in Research Electronic Data Capture (REDCap)
  • Able to take own blood pressure and record it in bi-weekly REDCap survey
  • Willing to participate in 12-week study and be assigned to either intervention or placebo arm
  • Not currently taking an omega-3 supplement or other high-dose supplement (over 2,000 IU) with potential for aiding recovery of long covid syndrome (e.g. zinc, Vit C, Elderberry).
  • Able to take/swallow six mini-pills daily
  • Able and willing to give a spot blood sample (2 drops) at baseline and end of study.

Who cannot join

  • Not a Team Member at Hackensack Meridian Health
  • Not age 18+
  • Unwilling to provide informed consent/ declined to take part
  • No formal diagnosis of COVID-19 via PCR test (if home test was done, team member must confirm via PCR test)
  • Were hospitalized for treatment of covid-19
  • Not experiencing 1+ ongoing covid-19 symptom being measured in this study (respiratory symptoms (shortness of breath, cough), fatigue, loss of taste, loss of smell)
Show all 16Show fewer
  • Symptom(s) have persisted for more than 12 weeks after initial infection
  • Symptom(s) did not coincide with covid-19 infection and were present prior to covid-19 infection
  • Does have soy allergy
  • Does have allergy to fish
  • Not able to participate in bi-weekly surveys in REDCap
  • Able to take own blood pressure and record it in bi-weekly REDCap survey
  • Not willing to participate in 12-week study and be assigned to either intervention or placebo arm
  • Currently taking an omega-3 supplement or other high-dose supplement (over 2,000 IU) with potential for aiding recovery of long covid syndrome (e.g. zinc, Vit C, Elderberry).
  • Unable to take/swallow six mini-pills daily
  • Not able and not willing to give a spot blood sample (2 drops) at baseline and end of study.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Susan Dara

    Edison, New Jersey, 08820

Other trials in United States

About this study

Official title: Feasibility Pilot Clinical Trial of Omega-3 (EPA+DHA) Supplement vs. Placebo for Post-Acute Sequelae of Coronavirus-19 (COVID-19) Recovery Among Health Care Workers

This is a two-arm, double blind randomized 12-week study to supplement omega-3 (Eicosapentaenoic acid - EPA + docosahexaenoic acid - DHA) among 100 adults (age 18+) who had coronavirus-19 (covid-19) and are experiencing possible after-effects from post-acute sequelae of covid-19 (also called post-covid syndrome or long covid syndrome).

Read the detailed description

This is a double-blind, randomized controlled trial (RCT) with two treatment arms:

Arm 1 - Omega-3 (Eicosapentaenoic acid - EPA + docosahexaenoic acid - DHA) - Dose is 2,100mg per day via 3 mini-capsules, 2x/day (a total of 6 mini-capsules per day). Each capsule has 252mg of EPA and 102mg of DHA.

Support for dosing:

  • The American Heart Association (AHA) says taking up to 3 grams of fish oil daily in supplement form is considered safe;
  • Up to 5,000mg of omega-3 fatty acids per day is considered safe;
  • The U.S. Food and Drug Administration recommends consuming no more than 3 g/day of EPA and DHA combined, including up to 2 g/day from dietary supplements.

Arm 2 - Placebo - made from soybean oil (same dosing schedule as intervention arm)

Conditions
COVID-19
Being tested
Omega-3 (EPA+DHA), Placebo
Keywords
post-acute sequelae of covid-19, post- covid syndrome, long covid syndrome, healthcare workers, post-covid symptoms, quality of life, omega-3
Medical subject headings
COVID-19, Post-Acute COVID-19 Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Omega-3 (EPA+DHA)Drug

    Also called fish oil

    Dose is 2,100mg per day via 3 mini-capsules, 2x/day (a total of 6 mini-capsules per day).

    Each capsule has 252mg of EPA and 102mg of DHA.

  • PlaceboDrug

    3 Soybean Oil Placebo capsules

Study groups in NCT05121766
Study groupRoleWhat they receive
Study arm - Omega 3 supplementExperimentalOmega-3 (EPA+DHA) - Dose is 2,100mg per day via 3 mini-capsules, 2x/day (a total of 6 mini-capsules per day). Each capsule has 252mg of EPA and 102mg of DHA.
Receives: Drug: Omega-3 (EPA+DHA)
Control arm - placeboPlacebo comparator3 Soybean Oil Placebo capsules 2x/day (a total of 6 mini-capsules per day).
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility Study for Omega-3 Fatty Acid Supplementation v. Placebo in Adult Patients to Limit Long Covid Syndrome - Compliance as Captured by the Number of Participants Who Remain Compliant for the Whole Duration of the Study by Taking All Pills Daily

    Number of participants who remain compliant for 12 weeks

    Measured: 12 weeks

  2. Feasibility Study for Omega-3 Fatty Acid Supplementation v. Placebo in Adult Patients to Limit Long Covid Syndrome - Recruitment as Illustrated by the Number of Screen Failures (Potential Participants Approached But Not Interested in Participating).

    Number of participants who expressed interest in learning about the study

    Measured: 6 months recruitment efforts (starting on actual study start date)

  3. Feasibility Study for Omega-3 Fatty Acid Supplementation v. Placebo in Adult Patients to Limit Long Covid Syndrome - Retention as Illustrated by the Number of Participants That Initiate But do Not Complete the Study.

    Number of participants who initiate but do not complete study

    Measured: 12 weeks

Secondary outcomes (5)

  1. Impact of Omega-3 Supplement on Post-covid Symptoms - Shortness of Breath

    Self-reported shortness of breath as captured at baseline (self-completing survey-pre) and after 12 weeks of treatment with omega-3 (self-completing survey-post).

    Measured: 12 weeks from baseline

  2. Impact of Omega-3 Supplement on Post-covid Symptoms - Cough

    Self-reported cough as captured at baseline (self-completing survey-pre) and after 12 weeks of treatment with omega-3 (self-completing survey-post).

    Measured: 12 weeks from baseline

  3. Impact of Omega-3 Supplement on Post-covid Symptoms - Fatigue

    Self-reported fatigue as captured at baseline (self-completing survey-pre) and after 12 weeks of treatment with omega-3 (self-completing survey-post).

    Measured: 12 weeks from baseline

  4. Impact of Omega-3 Supplement on Post-covid Symptoms - Loss of Smell

    Self-reported loss of smell as captured at baseline (self-completing survey-pre) and after 12 weeks of treatment with omega-3 (self-completing survey-post).

    Measured: 12 weeks from baseline

  5. Impact of Omega-3 Supplement on Post-covid Symptoms - Loss of Taste

    Self-reported loss of taste as captured at baseline (self-completing survey-pre) and after 12 weeks of treatment with omega-3 (self-completing survey-post).

    Measured: 12 weeks from baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Nov 2021
  2. Study start10 Jan 2022
  3. Primary completion21 Apr 2023
  4. Study completion21 Apr 2023

Why it stopped: Challenges in enrollment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05121766
Sponsor's protocol ID
Pro2020-1166
Status last verified
Sep 2024
First submitted
15 Nov 2021
Last updated
19 Sep 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 1. BourBour F, Mirzaei Dahka S, Gholamalizadeh M, et al. Nutrients in prevention, treatment, and management of viral infections; special focus on Coronavirus [published online ahead of print, 2020 Jul 9]. Arch Physiol Biochem. 2020;1-10. doi:10.1080/13813455.2020.1791188 2. Ali N. Role of vitamin D in preventing of COVID-19 infection, progression and severity [published online ahead of print, 2020 Jun 20]. J Infect Public Health. 2020;S1876-0341(20)30531-1. doi:10.1016/j.jiph.2020.06.021 3. Colunga Biancatelli RML, Berrill M, Catravas JD, Marik PE. Quercetin and Vitamin C: An Experimental, Synergistic Therapy for the Prevention and Treatment of SARS-CoV-2 Related Disease (COVID-19). Front Immunol. 2020;11:1451. Published 2020 Jun 19. doi:10.3389/fimmu.2020.01451 4.Torjesen I. Covid-19: Public health agencies review whether vitamin D supplements could reduce risk. BMJ. 2020;369:m2475. Published 2020 Jun 19. doi:10.1136/bmj.m2475 5.Hribar CA, Cobbold PH, Church FC. Potential Role of Vitamin D in the Elderly to Resist COVID-19 and to Slow Progression of Parkinson's Disease. Brain Sci. 2020;10(5):284. Published 2020 May 8. doi:10.3390/brainsci10050284 6. NIH Workshop on Post-Acute Sequelae of COVID-19. Accessed 25 Jan 2021. Available at: https://www.niaid.nih.gov/news-events/workshop-post-acute-sequelae-covid-19 7. Mayo Clinic: COVID-19 (coronavirus): Long-term Effects. Accessed 8 Jan 2021 from https://www.mayoclinic.org/diseases-conditions/coronavirus/in-depth/coronavirus-long-term-effects/art-20490351 8. Jacobs LG, Gourna Paleoudis E, Lesky-Di Bari D, et al. Persistence of symptoms and quality of life at 35 days after hospitalization for COVID-19 infection. PLoS One. 2020;15(12):e0243882. Published 2020 Dec 11. doi:10.1371/journal.pone.0243882 9. Halpin SJ, McIvor C, Whyatt G, Adams A, Harvey O, McLean L, Walshaw C, Kemp S, Corrado J, Singh R, Collins T, O'Connor RJ, Sivan M. Postdischarge symptoms and rehabilitation needs in survivors of COVID-19 infection: A cross-sectional evaluation. J Med Virol. 2021 Feb;93(2):1013-1022. doi: 10.1002/jmv.26368. Epub 2020 Aug 17. PMID: 32729939. 10. Garrigues E, Janvier P, Kherabi Y, et al. Post-discharge persistent symptoms and health-related quality of life after hospitalization for COVID-19. J Infect. 2020;81(6):e4-e6. doi:10.1016/j.jinf.2020.08.029

  • 11. CDC Morbidity and Mortality Weekly Report: Symptom Duration and Risk Factors for Delayed Return to Usual Health Among Outpatients with Covid-19 in a Multistate Health Care Systems Network - United States - March-June 2020. Accessed on 25 Jan 2021 from https://www.cdc.gov/mmwr/volumes/69/wr/mm6930e1.htm 12. Couzin-Frankel, J. From 'brain fog' to heart damage, COVID-19's lingering problems alarm scientists. July 31, 2020. Accessed 25 January 2021 from https://www.sciencemag.org/news/2020/07/brain-fog-heart-damage-covid-19-s-lingering-problems-alarm-scientists 13. Cooney, Elizabeth. Stat / Health Column: Long after the fire of a covid-19 infection, mental and neurological effects can still smolder. Accessed 26 Jan 2021 from https://www.statnews.com/2020/08/12/after-covid19-mental-neurological-effects-smolder/ 14. Puntmann VO, Carerj ML, Wieters I, et al. Outcomes of Cardiovascular Magnetic Resonance Imaging in Patients Recently Recovered From Coronavirus Disease 2019 (COVID-19). JAMA Cardiol. 2020;5(11):1265-1273. doi:10.1001/jamacardio.2020.3557 15. Carfì A, Bernabei R, Landi F, for the Gemelli Against COVID-19 Post-Acute Care Study Group. Persistent Symptoms in Patients After Acute COVID-19. JAMA. 2020;324(6):603-605. doi:10.1001/jama.2020.12603 16. Gemelli Against COVID-19 Post-Acute Care Study Group. Post-COVID-19 global health strategies: the need for an interdisciplinary approach. Aging Clin Exp Res. 2020 Aug;32(8):1613-1620. doi: 10.1007/s40520-020-01616-x. Epub 2020 Jun 11. PMID: 32529595; PMCID: PMC7287410. 17. Scaioli E, Liverani E, Belluzzi A. The Imbalance between n-6/n-3 Polyunsaturated Fatty Acids and Inflammatory Bowel Disease: A Comprehensive Review and Future Therapeutic Perspectives. Int. J. Mol. Sci. 2017; 18(12): e2619 18.Yaqoob, P. Mechanisms underlying the immunomodulatory effects of n-3 PUFA. Proc. Nutr. Soc. 2010; 69(3): 311-315 19.Rees D, Miles EA, Banerjee T, Wells SJ, Roynette CE, Wahle KW, Calder PC. Dose-related effects of eicosapentaenoic acid on innate immune function in healthy humans: A comparison of young and older men. Am. J. Clin. Nutr. 2006; 83: 331-342 20. Endres S, Ghorbani R, Kelley VE, Georgilis K, Lonnemann G, van der Meer JW, Cannon JG, Rogers TS, Klempner MS, Weber PC, Schaefer EJ, Wolff SM, Dinarello CA. The effect of dietary supplementation with n-3 polyunsaturated fatty acids on the synthesis of interleukin-1 and tumor necrosis factor by mononuclear cells. N. Engl. J. Med. 1989; 320: 265-271

  • 21.Kelei Li, Tao Huang, Jusheng Zheng, Duo Li. Effect of Marine-Derived n-3 Polyunsaturated Fatty Acids on C-Reactive Protein, Interleukin 6 and Tumor Necrosis Factor a: A Meta-Analysis. PLOS ONE, 2014;9(2): e88103 22. Mogensen TH, Melchjorsen J, Hollsberg P, Paludan SR. Activation of NF-kappa B in virus-infected macrophages is dependent on mitochondrial oxidative stress and intracellular calcium: Downstream involvement of the kinases TGF-beta-activated kinase 1, mitogen-activated kinase/extracellular signal-regulated kinase kinase 1, and I kappa B kinase. J Immunol. 2003; 170(12): 6224- 6233 23.Beyazit Y, Purnak T, Kekilli M. Role of nitric oxide in the treatment of non-alcoholic fatty liver by omega-3 fatty acids. Aliment. Pharmacol. Ther. 2010; 32(2): 303-304 24. Adli M, Merkhofer E, Cogswell P, Baldwin AS. IKKalpha and IKKbeta each function to regulate NFkappaB activation in the TNF-induced/canonical pathway. PLoS One. 2010 Feb 25; 5(2): e9428 25. Sabater J, Masclans JR, Sacanell J, Chacon P, Sabin P, Plnas M. Effects of an omega-3 fatty acid enriched lipid emulsion on eicosanoid synthesis in acute respiratory distress syndrome (ARDS): A prospective, randomized, double-blind, parallel group study Nutr Metab (Lond). 2011; 8(1): 22. 26. Dushianthan A, Rebecca Cusack V, Burgess A, Grocott M, Calder P. Immunonutrition for Adults With ARDS: Results From a Cochrane Systematic Review and Meta-Analysis, Respiratory Care January 2020; 65(1): 99-110 27. Langlois P, D'Aragon F, Hardy G, Manzanares W. Omega-3 polyunsaturated fatty acids in critically ill patients with acute respiratory distress syndrome: A systematic review and meta-analysis. Nutrition. 2019; 61: 84-92 28. Chen H, Wang S, Zhao Y, Luo Y, Tong H, Su L. Correlation analysis of omega-3 fatty acids and mortality of sepsis and sepsis-induced ARDS in adults: data from previous randomized controlled trials. Nutr J. 2018; 17(1): 57 29. NBC News, NJ Gov. Murphy says state is hardest hit by coronavirus in U.S. May 12, 2020. Accessed at: https://www.nbcnews.com/video/new-jersey-gov-murphy-says-state-is-hardest-hit-by-coronavirus-in-u-s-83346501863 30. NJ Department of Health / Covid-19 Dashboard. Accessed 8 Jan 2021 from https://covid19.nj.gov/

  • 31. Barrett, E.S., Horton, D.B., Roy, J. et al. Prevalence of SARS-CoV-2 infection in previously undiagnosed health care workers in New Jersey, at the onset of the U.S. COVID-19 pandemic. BMC Infect Dis 20, 853 (2020). https://doi.org/10.1186/s12879-020-05587-2 32. Gooch, Kelly. Becker's Hospital Review: Covid-19 Sidelines over 100 New Jersey Hospital Workers. Dec 2, 2020. Accessed on 27 Jan 2021 from https://www.beckershospitalreview.com/workforce/covid-19-sidelines-over-100-new-jersey-hospital-workers.html. 33. American Heart Association: Professional Heart Daily (13 March 2017. Omega-3 Polyunsaturated Fatty Acid (Fish Oil) Supplementation and the Prevention of Clinical Cardiovascular Disease. Available at: https://professional.heart.org/en/science-news/omega-3-polyunsaturated-fatty-acid-fish-oil-supplementation-and-the-prevention 34. Scientific Opinion on the Tolerable Upper Intake Level of eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA) and docosapentaenoic acid (DPA). (Source: EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) / 27 July 2012 https://doi.org/10.2903/j.efsa.2012.2815|) 35.U.S. Food and Drug Administration. Summary of qualified health claims subject to enforcement discretion. 2014. Available at: https://www.fda.gov/food/food-labeling-nutrition/qualified-health-claims-letters-enforcement-discretion 36. Insights From the OPERA Randomized Trial--Emmanuel Akintoye , Prince Sethi, William S. Harris , Paul A. Thompson , Roberto Marchioli , Luigi Tavazzi , Roberto Latini , Mias Pretorius , Nancy J. Brown , Peter Libby, Dariush Mozaffarian, Originally published5 Nov 2018https://doi.org/10.1161/CIRCOUTCOMES.118.004584Circulation: Cardiovascular Quality and Outcomes. 2018;11 37. n-3 Fatty acids affect haemostasis but do not increase the risk of bleeding: clinical observations and mechanistic insights: John K Wachira, Mark K Larson, William S Harris; PMID: 24472372, DOI: 10.1017/S000711451300425X 38. Elevated plasma glucose and lowered triglyceride levels from omega-3 fatty acid supplementation in type II diabetes ; K E Friday , M T Childs, C H Tsunehara, W Y Fujimoto, E L Bierman, J W Ensinck--Diabetes Care . 1989 Apr; 12(4):276-81. doi:10.2337/diacare.12.4.276. 39. Effects of Omega-3 Fatty Acid Supplementation on Glucose Control and Lipid Levels in Type 2 Diabetes: A Meta-Analysis, Cai Chen, 1 , 2 Xuefeng Yu, 1 and Shiying Shao 1 ,* Published online 2015 Oct 2. doi: 10.1371/journal.pone.0139565 40. Morris MC, Sacks F, Rosner B. Does fish oil lower blood pressure? A meta-analysis of controlled trials. Circulation. 1993;88(2):523-533. doi:10.1161/01.cir.88.2.523 41. Cleveland Heart Lab: Omega-3 Fatty Acids: A Natural Way to Lower Blood Pressure. Blog post 20 August 2015. Available at: https://www.clevelandheartlab.com/blog/horizons-omega-3-fatty-acids-a-natural-way-to-lower-blood-pressure/ 42. Overview of Omega-3 Fatty Acid Therapies; J. Chris Bradberry, PharmD and Daniel E. Hilleman, PharmD----PMID: 24391388 43. Link, R. Healthline blog: 8 Little-Known Side Effects of Too Much Fish Oil. 17 July 2018. Available at: https://www.healthline.com/nutrition/fish-oil-side-effects#section4 44. Khodarahmi M, Azadbakht L. Dietary fat intake and functional dyspepsia. Adv Biomed Res. 2016;5:76. Published 2016 Apr 21. doi:10.4103/2277-9175.180988

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Omega-3 (EPA+DHA) in people with COVID-19, run by Hackensack Meridian Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility Study for Omega-3 Fatty Acid Supplementation v. Placebo in Adult Patients to Limit Long Covid Syndrome - Compliance as Captured by the Number of Participants Who Remain Compliant for the Whole Duration of the Study by Taking All Pills Daily (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05121766, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.

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