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

Hackensack Meridian Health

Status and phase: Terminated; Phase 1

Conditions: COVID-19

Treatments: Drug: Placebo; Drug: Omega-3 (EPA+DHA)

Study type: Interventional

Funder types: Other

Identifiers

NCT05121766

Pro2020-1166

Details and patient eligibility

About

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).

Full 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)

Enrollment: 32 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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32 participants in 2 patient groups, including a placebo group

Study arm - Omega 3 supplement

Experimental group

Description:

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.

Treatment:

Drug: Omega-3 (EPA+DHA)

Control arm - placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo