Abstract
Introduction:
The rate of sport-related concussion (SRC) has increased steadily over the past two decades in the pediatric population. Docosahexaenoic acid (DHA), an Omega-3 fatty acid important for brain development in children, may aid in recovery following SRC. The purpose of this study was to determine the feasibility, outcomes, and safety of DHA as early treatment for SRC in pediatrics.
Methods:
A double-blind, randomized, placebo-controlled feasibility trial was conducted. Inclusion criteria were ages 14-18 and SRC within 4 days of enrollment. Exclusion criteria included taking DHA, radiographic evidence of TBI, participation in motorized sports, or previous concussion within past 6 months.
Following diagnosis of concussion and initiation of standard treatment, subjects were randomized in a 1:1 fashion to DHA or a placebo and were instructed to take 2 capsules twice daily for 12 weeks. DHA capsules contained a total of 2000 mg of DHA/day and PLACEBO capsules contained corn and soy oil. Both were flavored with masking agents.
Subjects were followed prospectively. Standard clinical assessments, SCAT-3 symptoms, ImPACT scores, BESS scores, adverse effects, and drug compliance was collected at enrollment, 1-week, 2-weeks, 4-weeks and 12-weeks. Demographics, day of injury symptoms, injury characteristics, and sport played were also collected. Subjects who demonstrated normal neurocognitive testing, complete symptom resolution and were cleared to begin a return to play (RTP) progression prior to the 4-week follow-up visit were permitted to forgo additional study visits, but requested to return for the 12-week visit.
Groups were compared using Mann-Whitney tests for continuous variables and chi-square tests for categorical variables.
Results:
40 subjects were enrolled; 20 in the DHA group (mean age: 16.02 years; 65% male) and 20 in the PLACEBO group (mean age: 15.97 years; 70% male). No significant differences in demographics, sport, symptoms, ImPACT scores, or BESS scores at enrollment were noted between groups. 25 (62.5%) subjects completed the 12-week visit. Overall drug compliance was 61.57% in the DHA group compared to 66.34% in the PLACEBO group (p=0.727).
Subjects in the DHA group were symptom-free 4 days earlier than the PLACEBO group (16.1 vs. 20.9 days, p=0.082), demonstrated normal ImPACT neurocognitive testing (12.2 vs. 16.8 days, p=0.382), and were cleared to begin a RTP progression (21.4 vs. 23.4 days, p=0.115) sooner than those in the PLACEBO group.
Two adverse effects were noted in the DHA group. One event was determined to be unrelated to the study. The second event was drug-related eructation and considered minor. No adverse effects were reported in the PLACEBO group.
Conclusion:
This study demonstrated that use of high-dose DHA for treatment of SRC in pediatrics is feasible and safe. DHA may allow for a faster symptom-free state and for an earlier return to play, but a large-scale trial is needed.