CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 40 enrolled
Drug / intervention
Docosahexaenoic acid (DHA) +1 moredrug
Likely dose
Docosahexaenoic acid (DHA) 2 gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01903525
NCT01903525Phase 1Completed

Docosahexaenoic Acid (DHA) For The Treatment of Pediatric Concussion Related to Sports Injury

University of Texas Southwestern Medical Center·interventional·Posted Jul 19, 2013·Updated Jan 11, 2021

In Brief

A Phase 1 clinical trial evaluating Docosahexaenoic acid (DHA) and Placebo for Concussion and Mild Traumatic Brain Injury. Completed, enrolled 40 participants across 1 site.

Detailed Summary

In recent years, media attention has focused on the long-term sequelae of repeated concussive episodes in professional athletes. The growing understanding of the damage done by what was once considered a "ding" during a game or match, and the neurologic consequences of "playing through" or returning to play too soon has led to additional interest in and concern for pediatric athletes (18 or under) who experience sports-related concussions during game or practice play. Because it has only been in recent years that the full scope of damage done by repeated concussive episodes has come to light, very little research has been done on treatment of concussion in either adults or children. Brain injuries in children can be especially problematic, as the brain may continue to develop until the child reaches the age of 24 or older, so concussion during this time of development may be particularly damaging. Docosahexaenoic acid (DHA) is an omega-3 fatty acid commonly found in both fish oils and algae. DHA is known to improve development of the eyes and brain in young children. It is thought to be an effective anti-inflammatory and anti-oxidant, and since it occurs naturally and causes very few harmful side effects, it may be a useful compound in the treatment of pediatric concussion. This is a feasibility trial of DHA for the treatment of sports concussion in a pediatric population. The investigators' primary aim is to determine acceptability of randomization for this compound as well as rate of enrollment given our clinical population. The investigators' secondary aim is to examine preliminary outcomes. The investigators hypothesize that subjects who take 2 g of DHA daily for 3 months will see a shorter time to full recovery and return to play and a shorter time to resolve balance disturbance. These are good, albeit unvalidated, clinical indicators of concussive recovery.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 19, 2013
Enrollment StartSep 1, 2013
Primary CompletionAug 1, 2017
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 13.0 years ago

Interventions

Docosahexaenoic acid (DHA)drug

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.

Placebodrug

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.