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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-10

Study Completion Date

2023-04-21

Brief Summary

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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).

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Detailed Description

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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

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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

Study Groups

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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.

Group Type EXPERIMENTAL

Omega-3 (EPA+DHA)

Intervention Type DRUG

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.

Control arm - placebo

3 Soybean Oil Placebo capsules 2x/day (a total of 6 mini-capsules per day).

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

3 Soybean Oil Placebo capsules

Interventions

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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.

Intervention Type DRUG

Placebo

3 Soybean Oil Placebo capsules

Intervention Type DRUG

Other Intervention Names

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fish oil

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes