Ignite Creation Date:
2025-12-24 @ 4:22 PM
Ignite Modification Date:
2025-12-25 @ 2:17 PM
Study NCT ID:
NCT05121766
Status:
TERMINATED
Last Update Posted:
2024-09-19
First Post:
2021-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Feasibility Pilot Clinical Trial of Omega-3 Supplement vs. Placebo for Post Covid-19 Recovery Among Health Care Workers
Sponsor:
Hackensack Meridian Health
Organization:
Study Overview
Official Title:
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
Status:
TERMINATED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Challenges in enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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).
Detailed 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)
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: