Concussion
Conditions
Brief summary
The purpose of this study is to assess the efficacy of vitamin therapy in concussion when compared to placebo with respect to multiple endpoints including symptom severity, cognitive performance on computer based neuropsychological testing, post-concussion balance assessment, and post-concussion vestibular-oculomotor function.
Detailed description
To date, very little data exists on the use of vitamin supplementation to aid in the recovery of concussion. Data previously published shows potential benefit of certain vitamins in the management of migraine headache. These vitamins, Vitamin B2 (Riboflavin), Magnesium, Co-Enzyme Q-10, and Omega-3 fatty acids, at dosages described in the literature, are being used based on the migraine literature findings and anecdotal evidence to help treat complaints of headache in concussion management.
Interventions
DIETARY_SUPPLEMENTExperimental: Vitamin Mixture
Vitamins: B2 (riboflavin), magnesium, co-enzyme Q10, Omega 3 fatty acids
DIETARY_SUPPLEMENTPlacebo
Non-nutritional non-immunogenic non-allergic oil-based capsule with same appearance, weight and density of active experimental vitamin.
Sponsors
Rothman Institute Orthopaedics
Thomas Jefferson University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
11 Years to 22 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects ages 11-22 * Concussion within 7 days of enrollment * Presenting for treatment at Rothman Institute or Jefferson Concussion Center
Exclusion criteria
* Subjects with recent prior concussion within the past 30 days * Subjects with a history of moderate to severe TBI requiring hospitalization or resulting in prolonged symptoms (\>3weeks). * Subjects with known neurologic diagnosis associated with impaired cognitive function other that Attention Deficit Hyperactive Disorder or Attention Deficit Disorder. * Subjects with know allergy to algae, omega-3 fatty acid, or any component of the formulation. * Subjects currently requiring anticoagulants (ie- Warfarin), anti-platelets (ie- Aspirin, Plavix), or any non-steroidal anti-inflammatory drugs (ie- Ibuprofen, Naprosyn). * Subjects with known liver pathology or significantly elevated liver function tests (greater than 3 X normal). * Subjects with a current lower extremity injury that will affect postural stability testing. * Subjects who are pregnant and/or breast feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PCSI: Post-Concussion Symptom Inventory | 4 weeks |
Outcome results
None listed