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Vitamin Therapy in Concussion Management: A Randomized Control Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02382679
Recruitment Status : Terminated (Study was halted prematurely due to enrollment issues)
First Posted : March 9, 2015
Last Update Posted : April 13, 2022
Sponsor:
Collaborator:
Rothman Institute Orthopaedics
Information provided by (Responsible Party):
Thomas Jefferson University

Tracking Information
First Submitted Date  ICMJE March 3, 2015
First Posted Date  ICMJE March 9, 2015
Last Update Posted Date April 13, 2022
Actual Study Start Date  ICMJE March 2015
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 3, 2015)
PCSI: Post-Concussion Symptom Inventory [ Time Frame: 4 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vitamin Therapy in Concussion Management: A Randomized Control Trial
Official Title  ICMJE Vitamin Therapy in Concussion Management: A Randomized Control Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Concussion
Intervention  ICMJE
  • Dietary Supplement: Experimental: Vitamin Mixture
    Vitamins: B2 (riboflavin), magnesium, co-enzyme Q10, Omega 3 fatty acids
  • Dietary Supplement: Placebo
    Non-nutritional non-immunogenic non-allergic oil-based capsule with same appearance, weight and density of active experimental vitamin.
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Non-nutritional non-immunogenic non-allergic oil-based capsule with same appearance, weight and density of active experimental vitamin.
    Intervention: Dietary Supplement: Placebo
  • Experimental: Experimental: Vitamin Mixture
    Vitamin coenzyme Q10, magnesium, riboflavin and omega-3-fatty acid combination.
    Intervention: Dietary Supplement: Experimental: Vitamin Mixture
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 5, 2022)
20
Original Estimated Enrollment  ICMJE
 (submitted: March 3, 2015)
132
Actual Study Completion Date  ICMJE May 2016
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 11 Years to 22 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02382679
Other Study ID Numbers  ICMJE 14D.529
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Thomas Jefferson University
Study Sponsor  ICMJE Thomas Jefferson University
Collaborators  ICMJE Rothman Institute Orthopaedics
Investigators  ICMJE
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
PRS Account Thomas Jefferson University
Verification Date April 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP