High Dose Omega-3 Fatty Acids in the Treatment of Sport Related Concussions (NCT01814527) | Clinical Trial Compass
CompletedNot Applicable
High Dose Omega-3 Fatty Acids in the Treatment of Sport Related Concussions
United States62 participantsStarted 2013-07
Plain-language 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 cognitive and physical rest until symptoms resolve with a graduated return to activity. High dose omega-3 fatty acids have shown to have anti-inflammatory, anti-oxidant, and membrane stabilizing properties. They have also been used in treatment of severe traumatic brain injury. The purpose of this study is to determine if early high dose omega-3 fatty acid supplementation in Division I National Collegiate Athletic Association (NCAA) athletes that have sustained a concussion will decrease the number of days out of competitive sports with a quicker symptom resolution, return to baseline neurocognitive functioning and postural stability using a randomized double blind placebo controlled study design. Once an athlete is identified as having sustained a concussion by the East Carolina University Sports Medicine staff and qualifies for the study, he/she will randomly be assigned to either high dose omega-3 fatty acid or placebo. Both groups will undergo standard and usual care for concussed athletes at East Carolina University. The number of days it takes the athlete to return to competitive athletics will be recorded, along with time to symptom resolution, normalization of their computerized neurocognitive testing (ImPact) and computerized postural stability testing (Biodex BioSway).
Who can participate
Age range18 Years ā 40 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
ā. East Carolina University NCAA Division I athlete.
ā. Have sustained a concussion within the past 24 hours.
ā. A neurological exam not consistent with concern for an intracranial hemorrhage or other significant pathology.
ā. Must be at least 18 years old.
Exclusion criteria
ā. Subjects with a recent prior concussion within the past 30 days.
ā. Subjects with a history of moderate to severe TBI that has required hospitalization or resulted in prolonged signs and/or symptoms (\>3 weeks).
ā. Subjects with a known neurological diagnosis associated with impaired cognitive function other than Attention Deficit Hyperactive Disorder or Attention Deficit Disorder.
ā. Subjects already routinely using omega-3/DHA supplementation.
ā. Subjects with a known allergy to algae, omega-3 fatty acid, or any component of the formulation.
What they're measuring
1
Number of Days to Return to Full Unrestricted Athletic Participation