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Vitamin Therapy in Concussion Management: A Randomized Control Trial

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ClinicalTrials.gov Identifier: NCT02382679
Recruitment Status : Unknown
Verified January 2016 by Thomas Jefferson University.
Recruitment status was:  Active, not recruiting
First Posted : March 9, 2015
Last Update Posted : January 6, 2016
Sponsor:
Collaborator:
Rothman Institute Orthopaedics
Information provided by (Responsible Party):
Thomas Jefferson University

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.

Condition or disease Intervention/treatment Phase
Concussion Dietary Supplement: Experimental: Vitamin Mixture Dietary Supplement: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vitamin Therapy in Concussion Management: A Randomized Control Trial
Study Start Date : March 2015
Estimated Primary Completion Date : May 2016
Estimated Study Completion Date : May 2016

Arm Intervention/treatment
Placebo Comparator: Placebo
Non-nutritional non-immunogenic non-allergic oil-based capsule with same appearance, weight and density of active experimental vitamin.
Dietary Supplement: Placebo
Non-nutritional non-immunogenic non-allergic oil-based capsule with same appearance, weight and density of active experimental vitamin.

Experimental: Experimental: Vitamin Mixture
Vitamin coenzyme Q10, magnesium, riboflavin and omega-3-fatty acid combination.
Dietary Supplement: Experimental: Vitamin Mixture
Vitamins: B2 (riboflavin), magnesium, co-enzyme Q10, Omega 3 fatty acids




Primary Outcome Measures :
  1. PCSI: Post-Concussion Symptom Inventory [ Time Frame: 4 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 22 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02382679


Sponsors and Collaborators
Thomas Jefferson University
Rothman Institute Orthopaedics
Investigators
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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
Publications:
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Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT02382679    
Other Study ID Numbers: 14D.529
First Posted: March 9, 2015    Key Record Dates
Last Update Posted: January 6, 2016
Last Verified: January 2016
Additional relevant MeSH terms:
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Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs