Vitamin Therapy in Concussion Management: A Randomized Control Trial

NCT02382679 | Terminated

• 1 other identifier: 14D.529
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Concussion

Outcome Measures

Primary Outcomes (1)

• PCSI: Post-Concussion Symptom Inventory

  4 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Experimental: Vitamin Mixture

EXPERIMENTAL

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

Dietary Supplement: Experimental: Vitamin Mixture

Interventions

Experimental: Vitamin Mixture DIETARY_SUPPLEMENT

Vitamins: B2 (riboflavin), magnesium, co-enzyme Q10, Omega 3 fatty acids

Experimental: Vitamin Mixture

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 11 Years - 22 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Subjects ages 11-22
• Concussion within 7 days of enrollment
• Presenting for treatment at Rothman Institute or Jefferson Concussion Center

You may not qualify if:

• 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.

Sponsors & Collaborators

• Thomas Jefferson University: lead
• Rothman Institute Orthopaedics: collaborator

Related Publications (5)

• 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.

  PMID: 15728298 BACKGROUND

• 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.

  PMID: 20464605 BACKGROUND

• 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.

  PMID: 20872034 BACKGROUND

• 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.

  PMID: 15196887 BACKGROUND

• 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 [RETIRED]: 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.

  PMID: 15623677 BACKGROUND

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2015
• First Posted: March 9, 2015
• Study Start: March 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: April 13, 2022

Record last verified: 2022-04