Clinical Trial: DHA For The Treatment of Pediatric Concussion Related to Sports Injury

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Docosahexaenoic Acid (DHA) For The Treatment of Pediatric Concussion Related to Sports Injury

Brief Summary:

In recent years, media attention has focused on the long-term sequelae of repeated concussive episodes in professional athletes. The growing understanding of the damage done by what was once considered a "ding" during a game or match, and the neurologic consequences of "playing through" or returning to play too soon has led to additional interest in and concern for pediatric athletes (18 or under) who experience sports-related concussions during game or practice play.

Because it has only been in recent years that the full scope of damage done by repeated concussive episodes has come to light, very little research has been done on treatment of concussion in either adults or children. Brain injuries in children can be especially problematic, as the brain may continue to develop until the child reaches the age of 24 or older, so concussion during this time of development may be particularly damaging.

Docosahexaenoic acid (DHA) is an omega-3 fatty acid commonly found in both fish oils and algae. DHA is known to improve development of the eyes and brain in young children. It is thought to be an effective anti-inflammatory and anti-oxidant, and since it occurs naturally and causes very few harmful side effects, it may be a useful compound in the treatment of pediatric concussion.

This is a feasibility trial of DHA for the treatment of sports concussion in a pediatric population. The investigators' primary aim is to determine acceptability of randomization for this compound as well as rate of enrollment given our clinical population. The investigators' secondary aim is to examine preliminary outcomes. The investigators hypothesize that subjects who take 2 g of DHA daily for 3 months will see a shorter time to full recovery and return to play and a shorter time

Detailed Summary:

This is a double-blind, randomized, placebo-controlled feasibility trial of DHA for the treatment of pediatric concussion related to sports-injury. The definition used for concussion is from the Consensus Statement on Concussion in Sport: the 3rd International Conference on Concussion in Sport (Br J Sports Med 2009;43:Suppl 1 i76-i84 doi:10.1136/bjsm.2009.058248) and will meet the following criteria:

  1. Direct blow to the head, face, neck or a blow elsewhere on the body with an "impulsive" force transmitted to the head.

  2. Rapid onset of short-lived impairment of neurologic function in one or more of the following clinical domains that resolves spontaneously:

    1. symptoms: somatic (eg, headache), cognitive (eg, feeling like in a fog) and/or emotional symptoms (eg, lability).
    2. physical signs (eg, loss of consciousness, amnesia).
    3. behavioural changes (eg, irritability).
    4. cognitive impairment (eg, slowed reaction times).
    5. sleep disturbance (eg, drowsiness).
  3. No abnormality on standard structural neuroimaging studies, if such neuroimaging studies are completed for a clinically-indicated reason. Note: neuroimaging is not a part of this study protocol. Study participants will not undergo neuroimaging as part of this study.

Subjects will be randomized in a 1:1 fashion. DHA is an omega-3 fatty acid that occurs naturally in fish oil and algae. There are many dietary supplements containing DHA available in the marketplace. Martek Biosciences provides an a
Sponsor: University of Texas Southwestern Medical Center

Current Primary Outcome: Number of subjects enrolled during set enrollment period. [ Time Frame: 1 year ]

Determine the willingness of patients to be randomized, the expected rate of enrollment based on the clinic population, and protocol adherence of enrolled study participants.


Original Primary Outcome: Same as current

Current Secondary Outcome: Time to return to competitive game play [ Time Frame: 1 year ]

Time to clearance to return to play (in days). Time to clearance to return to play was chosen as a clinically significant measurement for medical professionals in the sports medicine field. The investigators will determine clearance for return to full competitive game play (Stage 6 of graduated return to play protocol) according to Consensus Statement guidelines and following the law in Texas, House Bill 2038. Criteria for return to play include complete clinical recovery from the concussion including returning to baseline symptoms, exam and neurocognitive function and successful completion of a gradual return to play progression. We hypothesize that subjects who take 2 g of DHA daily for 3 months will see a shorter time to full recovery and return to play.


Original Secondary Outcome: Same as current

Information By: University of Texas Southwestern Medical Center

Dates:
Date Received: July 9, 2013
Date Started: September 2013
Date Completion: June 2018
Last Updated: May 9, 2017
Last Verified: May 2017