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The Impact of Riboflavin on Sports-related Concussion

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ClinicalTrials.gov Identifier: NCT02772237
Recruitment Status : Unknown
Verified August 2017 by Jeremy Kent, MD, University of Virginia.
Recruitment status was:  Recruiting
First Posted : May 13, 2016
Last Update Posted : August 11, 2017
Sponsor:
Collaborator:
James Madison University
Information provided by (Responsible Party):
Jeremy Kent, MD, University of Virginia

Brief Summary:
The purpose of this study is to investigate the effectiveness of riboflavin to decrease the duration of time for a student-athlete to return to participation in sports after a sports related concussion.

Condition or disease Intervention/treatment Phase
Sports-related Concussion Biological: Riboflavin Biological: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Impact of Riboflavin on Sports-related Concussion: A Randomized Control Trial
Study Start Date : August 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Riboflavin

Arm Intervention/treatment
Active Comparator: Treatment group
Riboflavin 400mg daily
Biological: Riboflavin
Riboflavin 400mg daily
Other Name: Vitamin B2

Placebo Comparator: Placebo group
Placebo
Biological: Placebo



Primary Outcome Measures :
  1. Time to return to participation in sports after a sports-related concussion [ Time Frame: 14 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All UVa and JMU student-athletes over the age of 18 years old who are diagnosed with a sports related concussion

Exclusion Criteria:

  • Less than 18 years old
  • Greater than 24 hours have elapsed since the concussion occurred.
  • The student-athlete has already participated in the study during which he/she took Riboflavin
  • Non-sports related concussion not incurred while participating in the sport or training for the sport. As an example, a student-athlete who sustains a concussion as a result of a motor vehicle accident will be excluded from the study for that concussion.
  • A previous concussion within the last 12 months.
  • Any concussion that is complicated by a cranial bleed, skull fracture, additional severe injury (e.g. torn knee ligament) that might affect the return to normal activities above and beyond the sport-related concussion.
  • If the student athlete is cognitively impaired to a level that prevents verbal communication, the consent will be deemed 'opted out' and the student-athlete will not be enrolled in the study.

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): NCT02772237


Contacts
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Contact: Jeremy Kent, MD 434-924-1165
Contact: Kent Diduch, MD

Locations
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United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22904
Contact: Jeremy B Kent         
Sponsors and Collaborators
University of Virginia
James Madison University
Publications:

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Responsible Party: Jeremy Kent, MD, Assistant Professor, University of Virginia
ClinicalTrials.gov Identifier: NCT02772237    
Other Study ID Numbers: 18882
First Posted: May 13, 2016    Key Record Dates
Last Update Posted: August 11, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Jeremy Kent, MD, University of Virginia:
concussion
sports-related concussion
mTBI
Riboflavin
Vitamin B2
Additional relevant MeSH terms:
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Riboflavin
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Vitamin B Complex
Photosensitizing Agents
Dermatologic Agents