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
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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).
详细描述
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Everybody but the pharmacy team dispensing the drug will be masked.
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Team member at Hackensack Meridian Health
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Omega-3 (EPA+DHA) (Drug)
Control arm - placebo
3 Soybean Oil Placebo capsules 2x/day (a total of 6 mini-capsules per day).
干预措施: Placebo (Drug)
结局指标
主要结局
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
时间窗: 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).
时间窗: 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.
时间窗: 12 weeks
Number of participants who initiate but do not complete study
次要结局
- Impact of Omega-3 Supplement on Post-covid Symptoms - Shortness of Breath(12 weeks from baseline)
- Impact of Omega-3 Supplement on Post-covid Symptoms - Cough(12 weeks from baseline)
- Impact of Omega-3 Supplement on Post-covid Symptoms - Loss of Smell(12 weeks from baseline)
- Impact of Omega-3 Supplement on Post-covid Symptoms - Loss of Taste(12 weeks from baseline)
- Impact of Omega-3 Supplement on Post-covid Symptoms - Fatigue(12 weeks from baseline)