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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
32
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.
3 Soybean Oil Placebo capsules
Susan Dara
Edison, New Jersey, United States
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
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)
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
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).
Time frame: 12 weeks from baseline
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).
Time frame: 12 weeks from baseline
Impact of Omega-3 Supplement on Post-covid Symptoms - Fatigue
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Self-reported fatigue as captured at baseline (self-completing survey-pre) and after 12 weeks of treatment with omega-3 (self-completing survey-post).
Time frame: 12 weeks from baseline
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).
Time frame: 12 weeks from baseline
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).
Time frame: 12 weeks from baseline