feasibility pilot clinical trial of omega-3 supplement vs. placebo for post covid-19 recovery among health care workers

Conditions: COVID-19

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).

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)

Eligibility criteria:
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.

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