Trial record 1 of 27 for:    Open Studies | "Brain Concussion"
Previous Study | Return to List | Next Study

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by East Carolina University
Sponsor:
Information provided by (Responsible Party):
David Bica DO, East Carolina University
ClinicalTrials.gov Identifier:
NCT01814527
First received: March 18, 2013
Last updated: November 29, 2013
Last verified: November 2013
  Purpose

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 Intervention
Mild Concussion
Brain Concussion
Cerebral Concussion
Dietary Supplement: Docosahexaenoic acid
Other: Placebo

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by East Carolina University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 100
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)
Arms Assigned Interventions
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.
Other: Placebo
5 capsules that are identical to the treatment.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01814527

Contacts
Contact: David P Bica, DO 401-651-8666 dbica04@gmail.com
Contact: Joseph Armen, DO 252-328-6841 armenj@ecu.edu

Locations
United States, North Carolina
East Carolina University Recruiting
Greenville, North Carolina, United States, 27834
Contact: David P Bica, DO    401-651-8666    dbica04@gmail.com   
Contact: Mike Hanley, ATC    252-414-1087    hanleym@ecu.edu   
Principal Investigator: Joseph Armen, DO         
Sponsors and Collaborators
East Carolina University
Investigators
Principal Investigator: David P Bica, DO East Carolina University
Principal Investigator: Joseph Armen, DO East Carolina University
  More Information

Publications:

Responsible Party: David Bica DO, Clinical Assistant Professor, East Carolina University
ClinicalTrials.gov Identifier: NCT01814527     History of Changes
Other Study ID Numbers: DSM-2012-1059
Study First Received: March 18, 2013
Last Updated: November 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by East Carolina University:
Fish oil
Omega 3 Fatty acids
Docosahexaenoic acid
Mild Concussion
Brain Concussion
Cerebral Concussion

Additional relevant MeSH terms:
Brain Concussion
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Head Injuries, Closed
Wounds and Injuries
Wounds, Nonpenetrating

ClinicalTrials.gov processed this record on July 22, 2014