DHA For The Treatment of Pediatric Concussion Related to Sports Injury

NCT01903525 | Completed Phase 1 Results

• 1 other identifier: STU 042012-055
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Concussion; Mild Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• Safety of Higher Dosage of DHA

  Determine the safety of a higher dosage of DHA through reported drug-related adverse events during the study period.

  12 weeks

Secondary Outcomes (3)

• Drug Adherence During Study Period

  12 weeks

• Time to Initiation of the Return to Sport (RTS) Progression

  12 weeks

• Resolution of Balance Impairment

  12 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Docosahexaenoic Acid (DHA)

EXPERIMENTAL

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.

Drug: Docosahexaenoic acid (DHA)

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.

Docosahexaenoic Acid (DHA)

Placebo 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.

Placebo

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Children's Medical Center Dallas: collaborator
• Texas Scottish Rite Hospital for Children: collaborator

Study Sites (1)

Sports Medicine at Texas Scottish Rite Hospital for Children

Plano, Texas, 75093, United States

Location

Related Publications (1)

• Miller SM, Zynda AJ, Sabatino MJ, Jo C, Ellis HB, Dimeff RJ. A Pilot Randomized Controlled Trial of Docosahexaenoic Acid for the Treatment of Sport-Related Concussion in Adolescents. Clin Pediatr (Phila). 2022 Nov;61(11):785-794. doi: 10.1177/00099228221101726. Epub 2022 Jun 19.

  PMID: 35722886 DERIVED

MeSH Terms

Conditions

Brain Concussion

Interventions

Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Results Point of Contact

• Title: Dr. Shane Miller
• Organization: Scottish Rite for Children

shane.miller@tsrh.org

469-515-7222

Study Officials

• Shane Miller, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Associate Professor of Orthopaedics and Pediatrics

Study Record Dates

• First Submitted: July 9, 2013
• First Posted: July 19, 2013
• Study Start: September 1, 2013
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: January 11, 2021
• Results First Posted: January 11, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)