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Omega-3 Fatty Acid Derivatives
Omega 3 fatty acid for Traumatic Brain Injury
Phase 2
Waitlist Available
Led By Ramon Diaz-Arrastia, MD, PhD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Documented/ verified TBI
Age 18-55
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 days consecutively
Awards & highlights
Study Summary
This trial is designed to see if n-3 HUFA can help improve outcomes after TBI by looking at the relationship between the dose of n-3 HUFA and its bioactive derivatives.
Eligible Conditions
- Traumatic Brain Injury
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 14 days consecutively
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 days consecutively
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Relationship of varying doses of n-3 HUFAs on blood levels of the following bioactive metabolites
Secondary outcome measures
Evalute potential adverse events
Relationship of n-3 HUFA blood levels and clinical outcomes measured by the Glasgow Outcome Scale-Extended (GOSE)
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: 4,000 mg/day n-3 HUFAExperimental Treatment1 Intervention
Subjects will take 2 capsules twice daily starting at enrollment (within 24 hours of injury) for 14 consecutive days.
Group II: 1,000mg/day n-3 HUFAExperimental Treatment1 Intervention
Subjects will take one capsule daily starting at study enrollment (within 24 hours of injury) for 14 consecutive days.
Group III: 1 capsule safflower seed oilPlacebo Group1 Intervention
Subjects will take 1 capsule daily starting at enrollment (within 24 hours of injury) for 14 consecutive days.
Group IV: 4 capsules safflower seed oilPlacebo Group1 Intervention
Subjects will take 2 capsules twice daily starting at enrollment (within 24 hours of injury) for 14 consecutive days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Omega-3-acid ethyl esters
FDA approved
Find a Location
Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
1,992 Previous Clinical Trials
42,875,360 Total Patients Enrolled
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
791 Previous Clinical Trials
1,356,984 Total Patients Enrolled
Ramon Diaz-Arrastia, MD, PhDPrincipal Investigator - University of Pennsylvania
Hospital of the University of Pennsylvania, Penn Presbyterian Medical Center, Pennsylvania Hospital
Baylor College Of Medicine (Medical School)
Ny & Presby Hp-Columbia Campus (Residency)
11 Previous Clinical Trials
6,146 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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