Status:
COMPLETED
High Dose Omega-3 Fatty Acids in the Treatment of Sport Related Concussions
Lead Sponsor:
East Carolina University
Conditions:
Mild Concussion
Brain Concussion
Eligibility:
All Genders
18-40 years
Phase:
NA
Brief Summary
Concussions are defined as a complex pathophysiological process affecting the brain, induced by traumatic biomechanical forces. Currently the standard of care in the treatment for concussions is cogni...
Detailed Description
In the United States, an estimated 1.7 million people sustain a traumatic brain injury (TBI) annually; associated with 1.365 million emergency room visits and 275,000 hospitalizations annually with as...
Eligibility Criteria
Inclusion
- East Carolina University NCAA Division I athlete.
- Have sustained a concussion within the past 24 hours.
- A neurological exam not consistent with concern for an intracranial hemorrhage or other significant pathology.
- Must be at least 18 years old.
Exclusion
- Subjects with a recent prior concussion within the past 30 days.
- Subjects with a history of moderate to severe TBI that has required hospitalization or resulted in prolonged signs and/or symptoms (\>3 weeks).
- Subjects with a known neurological diagnosis associated with impaired cognitive function other than Attention Deficit Hyperactive Disorder or Attention Deficit Disorder.
- Subjects already routinely using omega-3/DHA supplementation.
- Subjects with a known allergy to algae, omega-3 fatty acid, or any component of the formulation.
- Subjects currently requiring anticoagulants (ie: Warfarin), anti-platelets (ie: aspirin, Plavix) or any Non-steroidal anti-inflammatory drugs (ie: Ibuprofen, Naprosyn).
- Subjects with known liver pathology or significantly elevated liver function tests (greater than 3 x normal).
- Subjects with a current lower extremity injury that will affect postural stability testing.
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2017
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT01814527
Start Date
July 1 2013
End Date
July 1 2017
Last Update
April 24 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
East Carolina University
Greenville, North Carolina, United States, 27834