High Dose Omega-3 Fatty Acids in the Treatment of Sport Related Concussions
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).
Dietary Supplement: Docosahexaenoic acid
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
|Official Title:||High Dose Omega-3 Fatty Acids in the Treatment of Sport Related Concussions|
- Number of days to return to full unrestricted athletic participation [ Time Frame: 30 days ] [ Designated as safety issue: No ]Primary outcome will be the total number of days from onset of concussion it takes for the athlete to return to unrestricted full participation in their respective sport.
- Number of days for balance and cognition to return to baseline [ Time Frame: 30 days ] [ Designated as safety issue: No ]One of the secondary outcome will be the rate of change in the ImPact composite raw scores and percentiles from time of injury to the time of final sport clearance. Each composite raw score with percentiles including verbal memory, visual memory, visual motor speed, reaction time, impulse control and total composite score will be analyzed. Another outcome will be the rate change in the Biodex BioSway from time of injury to time of final sport clearance.
|Study Start Date:||July 2013|
|Estimated Study Completion Date:||July 2016|
|Estimated Primary Completion Date:||July 2016 (Final data collection date for primary outcome measure)|
Active Comparator: Docosahexaenoic acid
The experimental group will be given a standardized dose of omega-3 fatty acid containing 2200mg of DHA for 30 days after onset of concussion or longer for those with continued symptomatology. Brain Armor an over the counter DHA supplements that is independently tested and certified by the National Science Foundation Athletic Banned Substance Certified for Sport Program. The Docosahexaenoic acid supplement has 440mg of DHA per capsule and each subject will be given 5 capsules of Brain Armor once daily for a DHA dose of 2200mg/day.
Dietary Supplement: Docosahexaenoic acid
5 capsules containing 440mg of Docosahexaenoic acid (DHA)for total daily dosing of 2200mg of DHA daily
Other Name: Omega-3 Fatty Acids
Placebo Comparator: Placebo
The placebo group will be given an equal amount of capsules.
5 capsules that are identical to the treatment.
Other Name: Placebo
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01814527
|Contact: David P Bica, DOemail@example.com|
|Contact: Joseph Armen, DOfirstname.lastname@example.org|
|United States, North Carolina|
|East Carolina University||Recruiting|
|Greenville, North Carolina, United States, 27834|
|Contact: David P Bica, DO 401-651-8666 email@example.com|
|Contact: Mike Hanley, ATC 252-414-1087 firstname.lastname@example.org|
|Principal Investigator: Joseph Armen, DO|
|Principal Investigator:||David P Bica, DO||East Carolina University|
|Principal Investigator:||Joseph Armen, DO||East Carolina University|