Clinical trial NCT02772237: The Impact of Riboflavin on Sports-related Concussion
Official title: The Impact of Riboflavin on Sports-related Concussion: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Sports-related Concussion
Keywords: concussion
sports-related concussion
mTBI
Riboflavin
Vitamin B2
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: James Madison University
First posted: 2016-05-13
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Time to return to participation in sports after a sports-related concussion
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
References:
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citation: Sundaram U. Regulation of intestinal vitamin B(2) absorption. Focus on "Riboflavin uptake by human-derived colonic epithelial NCM460 cells". Am J Physiol Cell Physiol. 2000 Feb;278(2):C268-9. doi: 10.1152/ajpcell.2000.278.2.C268. No abstract available.
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