Vitamin Therapy in Concussion Management: A Randomized Control Trial

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.

Study Overview

• Status: Terminated
• Conditions: Concussion
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Experimental: Vitamin Mixture

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 22 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Thomas Jefferson University
• Collaborators: Rothman Institute Orthopaedics
• Investigators: Principal Investigator: Steve Stache, MD, Rothman Institute; Principal Investigator: Mijail Serruya, MD, PhD, Thomas Jefferson University; Principal Investigator: Robert Franks, DO, Rothman Institute; Principal Investigator: Jeremy Close, MD, Thomas Jefferson University

Publications and helpful links

General Publications

• Sandor PS, Di Clemente L, Coppola G, Saenger U, Fumal A, Magis D, Seidel L, Agosti RM, Schoenen J. Efficacy of coenzyme Q10 in migraine prophylaxis: a randomized controlled trial. Neurology. 2005 Feb 22;64(4):713-5. doi: 10.1212/01.WNL.0000151975.03598.ED.
• Schiapparelli P, Allais G, Castagnoli Gabellari I, Rolando S, Terzi MG, Benedetto C. Non-pharmacological approach to migraine prophylaxis: part II. Neurol Sci. 2010 Jun;31 Suppl 1:S137-9. doi: 10.1007/s10072-010-0307-4.
• Esposito M, Carotenuto M. Ginkgolide B complex efficacy for brief prophylaxis of migraine in school-aged children: an open-label study. Neurol Sci. 2011 Feb;32(1):79-81. doi: 10.1007/s10072-010-0411-5. Epub 2010 Sep 25.
• Bianchi A, Salomone S, Caraci F, Pizza V, Bernardini R, D'Amato CC. Role of magnesium, coenzyme Q10, riboflavin, and vitamin B12 in migraine prophylaxis. Vitam Horm. 2004;69:297-312. doi: 10.1016/S0083-6729(04)69011-X.
• Lewis D, Ashwal S, Hershey A, Hirtz D, Yonker M, Silberstein S; American Academy of Neurology Quality Standards Subcommittee; Practice Committee of the Child Neurology Society. Practice parameter: pharmacological treatment of migraine headache in children and adolescents: report of the American Academy of Neurology Quality Standards Subcommittee and the Practice Committee of the Child Neurology Society. Neurology. 2004 Dec 28;63(12):2215-24. doi: 10.1212/01.wnl.0000147332.41993.90.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2015
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: March 3, 2015
• First Submitted That Met QC Criteria: March 3, 2015
• First Posted (Estimate): March 9, 2015

Study Record Updates

• Last Update Posted (Actual): April 13, 2022
• Last Update Submitted That Met QC Criteria: April 5, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Micronutrients; Vitamins
• Other Study ID Numbers: 14D.529

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No