DHA For The Treatment of Pediatric Concussion Related to Sports Injury

PHASE1CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

September 30, 2013

Primary Completion Date

August 31, 2017

Study Completion Date

August 31, 2017

Conditions
ConcussionMild Traumatic Brain Injury
Interventions
DRUG

Docosahexaenoic acid (DHA)

Subjects presenting with a new concussion within 4 days of their initial injury will be identified and screened for eligibility from the investigators' regularly scheduled clinic patients. Subjects who enroll will complete 5 scheduled visits, although additional visits may be clinically indicated for symptom evaluation and treatment. All assessments done for this study are routinely done as part of the standard clinic visits for concussion at the Sports Medicine Center. Subjects will be randomized to either DHA or placebo in a 1:1 ratio, and receive enough DHA or placebo capsules to reach the target dose of 2 g of DHA per day (or placebo) until the day of their next appointment. Subjects will be instructed to take 4 capsules (2 at breakfast and 2 at dinner) for 12 weeks.

DRUG

Placebo

Subjects presenting with a new concussion within 4 days of their initial injury will be identified and screened for eligibility from the investigators' regularly scheduled clinic patients. Subjects who enroll will complete 5 scheduled visits, although additional visits may be clinically indicated for symptom evaluation and treatment. All assessments done for this study are routinely done as part of the standard clinic visits for concussion at the Sports Medicine Center. Subjects will be randomized to either DHA or placebo in a 1:1 ratio, and receive enough DHA or placebo capsules to reach the target dose of 2 g of DHA per day (or placebo) until the day of their next appointment. Subjects will be instructed to take 4 capsules (2 at breakfast and 2 at dinner) for 12 weeks.

Trial Locations (1)

75093

Sports Medicine at Texas Scottish Rite Hospital for Children, Plano

All Listed Sponsors
collaborator

Children's Medical Center Dallas

OTHER

collaborator

Texas Scottish Rite Hospital for Children

OTHER

lead

University of Texas Southwestern Medical Center

OTHER

NCT01903525 - DHA For The Treatment of Pediatric Concussion Related to Sports Injury | Biotech Hunter | Biotech Hunter