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

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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05121766

Enrollment

Registered

2021-11-16

Start date

2022-01-10

Completion date

2023-04-21

Last updated

2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Keywords

post-acute sequelae of covid-19, post- covid syndrome, long covid syndrome, healthcare workers, post-covid symptoms, quality of life, omega-3

Brief 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 long covid syndrome).

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)

Interventions

DRUGOmega-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.

DRUGPlacebo

3 Soybean Oil Placebo capsules

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Everybody but the pharmacy team dispensing the drug will be masked.

Eligibility

Sex/Gender

ALL

Age

18 Years to 89 Years

Healthy volunteers

Yes

Inclusion criteria

* 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) * 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.

Exclusion criteria

* 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) * 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.

Design outcomes

Primary

Measure	Time frame	Description
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	12 weeks	Number of participants who remain compliant for 12 weeks
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).	6 months recruitment efforts (starting on actual study start date)	Number of participants who expressed interest in learning about the study
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.	12 weeks	Number of participants who initiate but do not complete study

Secondary

Measure	Time frame	Description
Impact of Omega-3 Supplement on Post-covid Symptoms - Loss of Smell	12 weeks from baseline	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).
Impact of Omega-3 Supplement on Post-covid Symptoms - Shortness of Breath	12 weeks from baseline	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).
Impact of Omega-3 Supplement on Post-covid Symptoms - Loss of Taste	12 weeks from baseline	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).
Impact of Omega-3 Supplement on Post-covid Symptoms - Cough	12 weeks from baseline	Self-reported cough as captured at baseline (self-completing survey-pre) and after 12 weeks of treatment with omega-3 (self-completing survey-post).
Impact of Omega-3 Supplement on Post-covid Symptoms - Fatigue	12 weeks from baseline	Self-reported fatigue as captured at baseline (self-completing survey-pre) and after 12 weeks of treatment with omega-3 (self-completing survey-post).

Countries

United States

Participant flow

Participants by arm

Arm	Count
Study Arm - Omega 3 Supplement Omega-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. Omega-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.	16
Control Arm - Placebo 3 Soybean Oil Placebo capsules 2x/day (a total of 6 mini-capsules per day). Placebo: 3 Soybean Oil Placebo capsules	16
Total	32

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	2	4
Overall Study	Covid reinfection	3	0
Overall Study	Lost to Follow-up	0	1
Overall Study	Withdrawal by Subject	3	1

Baseline characteristics

Characteristic	Study Arm - Omega 3 Supplement	Control Arm - Placebo	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	1 Participants	1 Participants
Age, Categorical Between 18 and 65 years	16 Participants	15 Participants	31 Participants
Age, Continuous	46.44 years	47.25 years	46.84 years
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants	2 Participants	4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants	14 Participants	28 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	1 Participants	0 Participants	1 Participants
Race (NIH/OMB) Black or African American	0 Participants	1 Participants	1 Participants
Race (NIH/OMB) More than one race	1 Participants	0 Participants	1 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	1 Participants	1 Participants
Race (NIH/OMB) White	14 Participants	14 Participants	28 Participants
Region of Enrollment United States	16 participants	16 participants	0 participants
Sex: Female, Male Female	15 Participants	14 Participants	29 Participants
Sex: Female, Male Male	1 Participants	2 Participants	3 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 16	0 / 16
other Total, other adverse events	1 / 16	5 / 16
serious Total, serious adverse events	0 / 16	0 / 16

Outcome results

Primary

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

Time frame: 12 weeks

Population: Number of participants who completed the 12-week intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Study Arm - Omega 3 Supplement	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	8 Participants
Control Arm - Placebo	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	10 Participants

Primary

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

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

Population: Potential participants expressing interest in the study

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Study Arm - Omega 3 Supplement	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).	Interested to participate but not eligible	60 Participants
Study Arm - Omega 3 Supplement	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).	Chose not to participate after learning more about the study	1 Participants
Study Arm - Omega 3 Supplement	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).	Signed consent	32 Participants

Primary

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

Time frame: 12 weeks

Population: Participants that consented but did not completed 12 weeks of medication

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Study Arm - Omega 3 Supplement	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.	8 Participants
Control Arm - Placebo	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.	6 Participants

Secondary

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).