Vitamin Therapy in Concussion Management: A Randomized Control Trial

• ClinicalTrials.gov Identifier: NCT02382679
• Recruitment Status: Terminated
• First Posted: March 9, 2015
• Last Update Posted: April 13, 2022
• Sponsor: Thomas Jefferson University
• Collaborator: Rothman Institute Orthopaedics
• Information provided by (Responsible Party): Thomas Jefferson University

Tracking Information

• First Submitted Date: March 3, 2015
• First Posted Date: March 9, 2015
• Last Update Posted Date: April 13, 2022
• Actual Study Start Date: March 2015
• Actual Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: March 3, 2015): PCSI: Post-Concussion Symptom Inventory [ Time Frame: 4 weeks ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Vitamin Therapy in Concussion Management: A Randomized Control Trial
• Official Title: Vitamin Therapy in Concussion Management: A Randomized Control Trial
• 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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Concussion

Intervention

• Dietary Supplement: Experimental: Vitamin Mixture
  Vitamins: B2 (riboflavin), magnesium, co-enzyme Q10, Omega 3 fatty acids
• Dietary Supplement: Placebo
  Non-nutritional non-immunogenic non-allergic oil-based capsule with same appearance, weight and density of active experimental vitamin.

Study Arms

• Placebo Comparator: Placebo
  Non-nutritional non-immunogenic non-allergic oil-based capsule with same appearance, weight and density of active experimental vitamin.
  Intervention: Dietary Supplement: Placebo
• Experimental: Experimental: Vitamin Mixture
  Vitamin coenzyme Q10, magnesium, riboflavin and omega-3-fatty acid combination.
  Intervention: Dietary Supplement: Experimental: Vitamin Mixture

Publications *

• Sándor 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.
• 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. Review.
• 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. Review.
• 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. Review.

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: April 5, 2022): 20
• Original Estimated Enrollment (submitted: March 3, 2015): 132
• Actual Study Completion Date: May 2016
• Actual Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 11 Years to 22 Years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT02382679
• Other Study ID Numbers: 14D.529
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Thomas Jefferson University
• Study 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

• PRS Account: Thomas Jefferson University
• Verification Date: April 2022