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

NCT01814527 | Completed Results

• 1 other identifier: DSM-2012-1059
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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).

Conditions

Mild Concussion; Brain Concussion; Cerebral Concussion

Keywords

Fish oil; Omega 3 Fatty acids; Docosahexaenoic acid; Mild Concussion; Brain Concussion; Cerebral Concussion

Outcome Measures

Primary Outcomes (1)

• Number of Days to Return to Full Unrestricted Athletic Participation

  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.

  30 days

Study Arms (2)

Docosahexaenoic acid

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

The placebo group will be given an equal amount of capsules.

Drug: Placebo

Interventions

Docosahexaenoic acid DIETARY_SUPPLEMENT

5 capsules containing 440mg of Docosahexaenoic acid (DHA)for total daily dosing of 2200mg of DHA daily

Also known as: Omega-3 Fatty Acids

Docosahexaenoic acid

Placebo DRUG

5 capsules that are identical to the treatment.

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• East Carolina University: lead

Study Sites (1)

East Carolina University

Greenville, North Carolina, 27834, United States

Location

Related Publications (12)

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  PMID: 16983222 BACKGROUND

• McCrory P, Meeuwisse W, Johnston K, Dvorak J, Aubry M, Molloy M, Cantu R. Consensus statement on concussion in sport - The 3rd international conference on concussion in sport held in Zurich, November 2008. PM R. 2009 May;1(5):406-20. doi: 10.1016/j.pmrj.2009.03.010. No abstract available.

  PMID: 19627927 BACKGROUND

• Giza CC, Hovda DA. The Neurometabolic Cascade of Concussion. J Athl Train. 2001 Sep;36(3):228-235.

  PMID: 12937489 BACKGROUND

• Ma DW, Seo J, Davidson LA, Callaway ES, Fan YY, Lupton JR, Chapkin RS. n-3 PUFA alter caveolae lipid composition and resident protein localization in mouse colon. FASEB J. 2004 Jun;18(9):1040-2. doi: 10.1096/fj.03-1430fje. Epub 2004 Apr 14.

  PMID: 15084525 BACKGROUND

• Li Q, Wang M, Tan L, Wang C, Ma J, Li N, Li Y, Xu G, Li J. Docosahexaenoic acid changes lipid composition and interleukin-2 receptor signaling in membrane rafts. J Lipid Res. 2005 Sep;46(9):1904-13. doi: 10.1194/jlr.M500033-JLR200. Epub 2005 Jun 1.

  PMID: 15930520 BACKGROUND

• Massaro M, Habib A, Lubrano L, Del Turco S, Lazzerini G, Bourcier T, Weksler BB, De Caterina R. The omega-3 fatty acid docosahexaenoate attenuates endothelial cyclooxygenase-2 induction through both NADP(H) oxidase and PKC epsilon inhibition. Proc Natl Acad Sci U S A. 2006 Oct 10;103(41):15184-9. doi: 10.1073/pnas.0510086103. Epub 2006 Oct 3.

  PMID: 17018645 BACKGROUND

• Massaro M, Basta G, Lazzerini G, Carluccio MA, Bosetti F, Solaini G, Visioli F, Paolicchi A, De Caterina R. Quenching of intracellular ROS generation as a mechanism for oleate-induced reduction of endothelial activation and early atherogenesis. Thromb Haemost. 2002 Aug;88(2):335-44.

  PMID: 12195709 BACKGROUND

• Endres S, Ghorbani R, Kelley VE, Georgilis K, Lonnemann G, van der Meer JW, Cannon JG, Rogers TS, Klempner MS, Weber PC, et al. The effect of dietary supplementation with n-3 polyunsaturated fatty acids on the synthesis of interleukin-1 and tumor necrosis factor by mononuclear cells. N Engl J Med. 1989 Feb 2;320(5):265-71. doi: 10.1056/NEJM198902023200501.

  PMID: 2783477 BACKGROUND

• Calder PC. Immunomodulation by omega-3 fatty acids. Prostaglandins Leukot Essent Fatty Acids. 2007 Nov-Dec;77(5-6):327-35. doi: 10.1016/j.plefa.2007.10.015. Epub 2007 Nov 26.

  PMID: 18032006 BACKGROUND

• Mills JD, Bailes JE, Sedney CL, Hutchins H, Sears B. Omega-3 fatty acid supplementation and reduction of traumatic axonal injury in a rodent head injury model. J Neurosurg. 2011 Jan;114(1):77-84. doi: 10.3171/2010.5.JNS08914. Epub 2010 Jul 16.

  PMID: 20635852 BACKGROUND

• McCrea M, Guskiewicz KM, Marshall SW, Barr W, Randolph C, Cantu RC, Onate JA, Yang J, Kelly JP. Acute effects and recovery time following concussion in collegiate football players: the NCAA Concussion Study. JAMA. 2003 Nov 19;290(19):2556-63. doi: 10.1001/jama.290.19.2556.

  PMID: 14625332 BACKGROUND

• Lucke-Wold B, Zasler ND, Ruchika F, Weisman S, Le D, Brunicardi J, Kong I, Ghumman H, Persad S, Mahan D, Delawan M, Shah S, Aghili-Mehrizi S. Supplement and nutraceutical therapy in traumatic brain injury. Nutr Neurosci. 2025 Jun;28(6):709-743. doi: 10.1080/1028415X.2024.2404782. Epub 2024 Dec 30.

  PMID: 40440029 DERIVED

MeSH Terms

Conditions

Brain Concussion

Interventions

Docosahexaenoic Acids; Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Results Point of Contact

• Title: Joseph Armen DO
• Organization: East Carolina University

armenj@ecu.edu

252-744-3212

Study Officials

• David P Bica, DO

  East Carolina University

  PRINCIPAL INVESTIGATOR

• Joseph Armen, DO

  East Carolina University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: March 18, 2013
• First Posted: March 20, 2013
• Study Start: July 1, 2013
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: April 24, 2024
• Results First Posted: April 24, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)