Trial record 7 of 9 for:    Open Studies | "Athletic Injuries"

DHA For The Treatment of Pediatric Concussion Related to Sports Injury

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2013 by University of Texas Southwestern Medical Center
Sponsor:
Collaborator:
Children's Medical Center Dallas
Information provided by (Responsible Party):
Shane Miller, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT01903525
First received: July 9, 2013
Last updated: July 16, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Concussion
Mild Traumatic Brain Injury
Drug: Docosahexaenoic acid (DHA)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Docosahexaenoic Acid (DHA) For The Treatment of Pediatric Concussion Related to Sports Injury

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Number of subjects enrolled during set enrollment period. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Determine the willingness of patients to be randomized, the expected rate of enrollment based on the clinic population, and protocol adherence of enrolled study participants.


Secondary Outcome Measures:
  • Time to return to competitive game play [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Time to clearance to return to play (in days). Time to clearance to return to play was chosen as a clinically significant measurement for medical professionals in the sports medicine field. The investigators will determine clearance for return to full competitive game play (Stage 6 of graduated return to play protocol) according to Consensus Statement guidelines and following the law in Texas, House Bill 2038. Criteria for return to play include complete clinical recovery from the concussion including returning to baseline symptoms, exam and neurocognitive function and successful completion of a gradual return to play progression. We 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.


Other Outcome Measures:
  • Resolution of Balance Impairment [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Improvement in balance impairment associated with the injury, as assessed by the Balance Error Scoring System (BESS) which is a component of the Sport Concussion Assessment Tool 3 (SCAT-3). We hypothesize a shorter time to resolve balance disturbance associated with the treatment of DHA.


Estimated Enrollment: 40
Study Start Date: September 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
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: 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.
Experimental: Docosahexaenoic Acid (DHA)
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)
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   14 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01903525

Contacts
Contact: Shane Miller, MD 469-303-3000 shane.miller@childrens.com
Contact: Evin Shirley, BS 214-456-9501 evin.shirley@childrens.com

Locations
United States, Texas
Sports Medicine at Childrens Medical Center at Legacy Not yet recruiting
Plano, Texas, United States, 75024
Contact: Shane Miller, MD    469-303-3000    shane.miller@childrens.com   
Contact: Robert Dimeff, MD    469-303-3000    Robert.Dimeff@UTSouthwestern.edu   
Principal Investigator: Shane Miller, MD         
Principal Investigator: Robert Dimeff, MD         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Children's Medical Center Dallas
Investigators
Principal Investigator: Shane Miler, MD University of Texas Southwestern Medical Center
  More Information

No publications provided

Responsible Party: Shane Miller, MD, Assistant Professor of Orthopaedics and Pediatrics, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01903525     History of Changes
Other Study ID Numbers: 042012-055
Study First Received: July 9, 2013
Last Updated: July 16, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Athletic Injuries
Brain Injuries
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System

ClinicalTrials.gov processed this record on July 23, 2014