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Phase 1 N=40 Randomized Quadruple-blind Treatment

DHA For The Treatment of Pediatric Concussion Related to Sports Injury

Concussion · Mild Traumatic Brain Injury

Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: Safety of Higher Dosage of DHA — 0; 1 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 1
Interventions
Docosahexaenoic acid (DHA) (Drug); Placebo (Drug)
Age
Pediatric, Adult · 14+ yrs
Sex
All
Sponsor
University of Texas Southwestern Medical Center
Primary completion
Aug 2017

Outcome Measures

OutcomeResultp-value
PRIMARY
Safety of Higher Dosage of DHA
0; 1
SECONDARY
Drug Adherence During Study Period
84.0; 74.7
SECONDARY
Time to Initiation of the Return to Sport (RTS) Progression
19.5; 14.0
SECONDARY
Resolution of Balance Impairment
4.15; 4.45; 3.21; 3.5; 3.94; 2.7

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 to resolve balance disturbance. These are good, albeit unvalidated, clinical indicators of concussive recovery.

Eligibility Criteria

Inclusion Criteria

  • Male or females age 14-18 inclusive
  • Diagnosed with concussion due to sports-related injury. Concussion is defined as:
  • Direct blow to the head, face, neck or a blow elsewhere on the body with an "impulsive" force transmitted to the head.
  • Rapid onset of short-lived impairment of neurologic function in one or more of the following clinical domains that resolves spontaneously:

i. Symptoms: somatic (eg, headache), cognitive (eg, feeling like in a fog and/or emotional symptoms (eg, lability).

ii. Physical signs (eg, loss of consciousness, amnesia).

iii. Behavioral changes (eg, irritability).

iv. Cognitive impairment (eg, slowed reaction times).

v. Sleep disturbance (eg, drowsiness). c) 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.

  • Concussion within 4 days of enrollment
  • Presenting for treatment to the Sports Medicine Center at Children's Medical Center

Exclusion Criteria

  • Subjects not actively participating in an organized sport at time of enrollment
  • Subjects who received a concussion from an event other than playing a sport (motor vehicle accident, fall, etc.)
  • Subjects who participate in or received a concussion during participation in motorized sports (i.e., motorcross, dirt biking, jet skiing, etc.)
  • Subjects with radiographic evidence of traumatic brain injury (i.e., skull fracture, intracranial hemorrhage, cerebral contusion, etc).
  • Subjects with a prior diagnosed concussion in the previous 6 months.
  • Pregnant women.
  • Subjects sensitive to aspirin
  • Subjects diagnosed with high blood pressure and currently being treated with blood pressure medications
  • Subjects allergic to soy bean oil or corn oil.
  • Subjects currently taking fish oil or DHA supplements.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01903525). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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