DHA For The Treatment of Pediatric Concussion Related to Sports Injury
Concussion · Mild Traumatic Brain Injury
Bottom Line
View on ClinicalTrials.gov: NCT01903525 ↗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
| Outcome | Result | p-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
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.
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.