Clinical Trial Details
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NCT01903525 : DHA For The Treatment of Pediatric Concussion Related to Sports Injury
PhasePhase 1
AgesMin: 14 Years Max: 18 Years
Inclusion Criteria:

1. Male or females age 14-18 inclusive

2. Diagnosed with concussion due to sports-related injury. Concussion is defined as:

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:

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.

3. Concussion within 4 days of enrollment

4. Presenting for treatment to the Sports Medicine Center at Children's Medical Center

Exclusion Criteria:

1. Subjects not actively participating in an organized sport at time of enrollment

2. Subjects who received a concussion from an event other than playing a sport (motor
vehicle accident, fall, etc.)

3. Subjects who participate in or received a concussion during participation in
motorized sports (i.e., motorcross, dirt biking, jet skiing, etc.)

4. Subjects with radiographic evidence of traumatic brain injury (i.e., skull fracture,
intracranial hemorrhage, cerebral contusion, etc).

5. Subjects with a prior diagnosed concussion in the previous 6 months.

6. Pregnant women.

7. Subjects sensitive to aspirin

8. Subjects diagnosed with high blood pressure and currently being treated with blood
pressure medications

9. Subjects allergic to soy bean oil or corn oil.

10. Subjects currently taking fish oil or DHA supplements.
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