Vitamin Therapy in Concussion Management: A Randomized Control Trial

NCT ID: NCT02382679

Last Updated: 2022-04-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2016-05-31

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.

Conditions

Concussion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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

Experimental: Vitamin Mixture

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

Group Type: EXPERIMENTAL

Experimental: Vitamin Mixture

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Experimental: Vitamin Mixture

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rothman Institute Orthopaedics

OTHER

Sponsor Role: collaborator

Thomas Jefferson University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steve Stache, MD

Role: PRINCIPAL_INVESTIGATOR

Rothman Institute

Mijail Serruya, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Thomas Jefferson University

Robert Franks, DO

Role: PRINCIPAL_INVESTIGATOR

Rothman Institute

Jeremy Close, MD

Role: PRINCIPAL_INVESTIGATOR

Thomas Jefferson University

References

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.

Reference Type: BACKGROUND

PMID: 15728298 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20464605 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20872034 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15196887 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15623677 (View on PubMed)

Other Identifiers

14D.529

Identifier Type: -

Identifier Source: org_study_id