Vitamin Therapy in Concussion Management: A Randomized Control Trial

Not Applicable

Terminated

• Conditions: Concussion
• Interventions: Dietary Supplement: Placebo

• Registration Number: NCT02382679
• Lead Sponsor: Thomas Jefferson University

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.

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-03-03
• Study First Submitted QC: 2015-03-03
• Study First Posted: 2015-03-09
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-05
• Last Update Posted: 2022-04-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Non-nutritional non-immunogenic non-allergic oil-based capsule with same appearance, weight and density of active experimental vitamin.

Primary Outcome Measures

Name	Time	Method
PCSI: Post-Concussion Symptom Inventory	4 weeks