Vitamin Therapy in Concussion Management: A Randomized Control Trial

Concussion Clinical Trial

Official title:

Vitamin Therapy in Concussion Management: A Randomized Control Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02382679
• Other study ID #: 14D.529
• Status: Terminated
• Phase: N/A
• Start date: March 2015
• Est. completion date: May 2016

Study information

• Verified date: April 2022
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 22 Years

Eligibility

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.

Related Conditions & MeSH terms

• Concussion

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Thomas Jefferson University	Rothman Institute Orthopaedics

References & Publications (5)

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. — View 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. — View 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: 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. — View Citation

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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PCSI: Post-Concussion Symptom Inventory		4 weeks