DHA For The Treatment of Pediatric Concussion Related to Sports Injury
Concussion, Mild Traumatic Brain Injury
About this trial
This is an interventional treatment trial for Concussion
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.
Sites / Locations
- Sports Medicine at Texas Scottish Rite Hospital for Children
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Experimental
Placebo
Docosahexaenoic Acid (DHA)
The placebo capsules are supplied as 950 mg capsules consisting of 475 mg corn oil and 475 mg soy oil. Both DHA and placebo are flavored with sweet orange flavoring and masking agents. Subjects will be instructed to take 2 capsules at breakfast and 2 capsules at dinner (with food). Subjects will take their first dose in the office to assure their ability to swallow the pills. Subjects will be dosed with the placebo for 12 weeks.
The DHASCO capsules are supplied as 950 mg capsules with an effective dose of 500 mg DHA per capsule. Both DHA and placebo are flavored with sweet orange flavoring and masking agents. Subjects will be instructed to take 2 capsules at breakfast and 2 capsules at dinner (with food). Subjects will take their first dose in the office to assure their ability to swallow the pills. Subjects will be dosed with the DHA for 12 weeks.