The Impact of Riboflavin on Sports-related Concussion
Phase 2
- Conditions
- Sports-related Concussion
- Registration Number
- NCT02772237
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 500
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Time to return to participation in sports after a sports-related concussion 14 days
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Virginia
🇺🇸Charlottesville, Virginia, United States
University of Virginia🇺🇸Charlottesville, Virginia, United StatesJeremy B KentContact