The Impact of Riboflavin on Sports-related Concussion

University of Virginia

Status and phase: Unknown; Phase 2

Conditions: Sports-related Concussion

Treatments: Biological: Riboflavin; Biological: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02772237

18882

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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500 participants in 2 patient groups, including a placebo group

Treatment group

Active Comparator group

Description:

Riboflavin 400mg daily

Treatment:

Biological: Riboflavin

Placebo group

Placebo Comparator group

Description:

Placebo

Treatment:

Biological: Placebo