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High Dose Omega-3 Fatty Acids in the Treatment of Sport Related Concussions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01814527
Recruitment Status : Completed
First Posted : March 20, 2013
Last Update Posted : September 19, 2017
Information provided by (Responsible Party):
David Bica DO, East Carolina University

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 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).

Condition or disease Intervention/treatment Phase
Mild Concussion Brain Concussion Cerebral Concussion Dietary Supplement: Docosahexaenoic acid Drug: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: High Dose Omega-3 Fatty Acids in the Treatment of Sport Related Concussions
Actual Study Start Date : July 2013
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.
Drug: Placebo
5 capsules that are identical to the treatment.

Primary Outcome Measures :
  1. Number of days to return to full unrestricted athletic participation [ Time Frame: 30 days ]
    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.

Secondary Outcome Measures :
  1. Number of days for balance and cognition to return to baseline [ Time Frame: 30 days ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. East Carolina University NCAA Division I athlete.
  2. Have sustained a concussion within the past 24 hours.
  3. A neurological exam not consistent with concern for an intracranial hemorrhage or other significant pathology.
  4. Must be at least 18 years old.

Exclusion Criteria:

  1. Subjects with a recent prior concussion within the past 30 days.
  2. Subjects with a history of moderate to severe TBI that has required hospitalization or resulted in prolonged signs and/or symptoms (>3 weeks).
  3. Subjects with a known neurological diagnosis associated with impaired cognitive function other than Attention Deficit Hyperactive Disorder or Attention Deficit Disorder.
  4. Subjects already routinely using omega-3/DHA supplementation.
  5. Subjects with a known allergy to algae, omega-3 fatty acid, or any component of the formulation.
  6. Subjects currently requiring anticoagulants (ie: Warfarin), anti-platelets (ie: aspirin, Plavix) or any Non-steroidal anti-inflammatory drugs (ie: Ibuprofen, Naprosyn).
  7. Subjects with known liver pathology or significantly elevated liver function tests (greater than 3 x normal).
  8. Subjects with a current lower extremity injury that will affect postural stability testing.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01814527

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United States, North Carolina
East Carolina University
Greenville, North Carolina, United States, 27834
Sponsors and Collaborators
East Carolina University
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Principal Investigator: David P Bica, DO East Carolina University
Principal Investigator: Joseph Armen, DO East Carolina University

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Responsible Party: David Bica DO, Clinical Assistant Professor, East Carolina University Identifier: NCT01814527    
Other Study ID Numbers: DSM-2012-1059
First Posted: March 20, 2013    Key Record Dates
Last Update Posted: September 19, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data in collection phase and not ready for analysis
Keywords provided by David Bica DO, East Carolina University:
Fish oil
Omega 3 Fatty acids
Docosahexaenoic acid
Mild Concussion
Brain Concussion
Cerebral Concussion
Additional relevant MeSH terms:
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Brain Concussion
Brain Injuries, Traumatic
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Head Injuries, Closed
Wounds and Injuries
Wounds, Nonpenetrating