Sports-related Concussion
Conditions
Keywords
concussion, sports-related concussion, mTBI, Riboflavin, Vitamin B2
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.
Interventions
BIOLOGICALRiboflavin
Riboflavin 400mg daily
BIOLOGICALPlacebo
Sponsors
James Madison University
University of Virginia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to return to participation in sports after a sports-related concussion | 14 days |
Countries
United States
Contacts
Primary ContactJeremy Kent, MD
Backup ContactKent Diduch, MD
Outcome results
None listed