The Impact of Riboflavin on Sports-related Concussion

Phase 2

• Conditions: Sports-related Concussion
• Interventions: Biological: Riboflavin; Biological: Placebo

• 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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-05-12
• Study First Submitted QC: 2016-05-12
• Study First Posted: 2016-05-13
• Study Start: 2016-08
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-09
• Last Update Posted: 2017-08-11
• Primary Completion: 2018-12
• Study Completion: 2019-12

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group	Riboflavin	Riboflavin 400mg daily
Placebo group	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Time to return to participation in sports after a sports-related concussion	14 days

Trial Locations

Locations (1)

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States