Clinical trial NCT02382679: Vitamin Therapy in Concussion Management: A Randomized Control Trial
Official title: Vitamin Therapy in Concussion Management: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Concussion
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: Rothman Institute Orthopaedics
First posted: 2015-03-09
Enrollment: 20
Sex: ALL
Minimum age (years): 11
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: PCSI: Post-Concussion Symptom Inventory
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Rothman Institute
name: Steve Stache, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Thomas Jefferson University
name: Mijail Serruya, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rothman Institute
name: Robert Franks, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: Thomas Jefferson University
name: Jeremy Close, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.