Recruiting
Phase 2

Riboflavin

Sponsor:

University of Virginia

Code:

NCT02772237

Conditions

Sports-related Concussion

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Riboflavin

Placebo

Study Details

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.

Conditions

Sports-related Concussion

Study ID

NCT02772237

Start date

Aug, 2016

Status verified date

Aug, 2017

Completion date

Dec, 2019

Anticipated

Primary completion date

Dec, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Enrollment

500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Treatment group

Riboflavin 400mg daily

placebo comparator: Placebo group

Placebo

Interventions

Riboflavin

Riboflavin 400mg daily

Placebo

Primary outcome measure

  • Time to return to participation in sports after a sports-related concussion [ Time Frame: 14 days ]

Central Contacts and Locations

Central contacts

Jeremy Kent, MD

434-924-1165

Locations

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22904

More Information

Sponsor

University of Virginia

Last update posted

Aug 11, 2017

Last verified

Aug, 2017

Keywords

  • concussion
  • sports-related concussion
  • mTBI
  • Riboflavin
  • Vitamin B2

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2017-08-11.