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The Impact of Riboflavin on Sports-related Concussion

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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

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

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

Trial contacts and locations

1

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Central trial contact

Jeremy Kent, MD; Kent Diduch, MD

Data sourced from clinicaltrials.gov

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