Vitamin Therapy in Concussion Management: A Randomized Control Trial

Thomas Jefferson University

Status: Terminated

Conditions: Concussion

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Experimental: Vitamin Mixture

Study type: Interventional

Funder types: Other

Identifiers

NCT02382679

14D.529

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 11 to 22 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo

Experimental: Vitamin Mixture

Experimental group

Description:

Vitamin coenzyme Q10, magnesium, riboflavin and omega-3-fatty acid combination.

Treatment:

Dietary Supplement: Experimental: Vitamin Mixture