Vitamin Therapy in Concussion Management: A Randomized Control Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Vitamin Therapy in Concussion Management: A Randomized Control Trial

Conditions
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Concussion

Intervention / Treatment
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* Dietary Supplement: Experimental: Vitamin Mixture
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Non-nutritional non-immunogenic non-allergic oil-based capsule with same appearance, weight and density of active experimental vitamin. | Dietary Supplement: Placebo<br>* Non-nutritional non-immunogenic non-allergic oil-based capsule with same appearance, weight and density of active experimental vitamin.<br>|
| Experimental: Experimental: Vitamin Mixture<br>Vitamin coenzyme Q10, magnesium, riboflavin and omega-3-fatty acid combination. | Dietary Supplement: Experimental: Vitamin Mixture<br>* Vitamins: B2 (riboflavin), magnesium, co-enzyme Q10, Omega 3 fatty acids<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PCSI: Post-Concussion Symptom Inventory |  | 4 weeks |