The Impact of Riboflavin on Sports-related Concussion

August 9, 2017 updated by: Jeremy Kent, MD, University of Virginia

The Impact of Riboflavin on Sports-related Concussion: A Randomized Control Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22904
        • Recruiting
        • University of Virginia
        • Contact:
          • Jeremy B Kent

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Treatment group
Riboflavin 400mg daily
Biological: Riboflavin
Riboflavin 400mg daily
Other Names:
  • Vitamin B2
PLACEBO_COMPARATOR: Placebo group
Placebo
Biological: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to return to participation in sports after a sports-related concussion
Time Frame: 14 days
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Collaborators

James Madison University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (ANTICIPATED)

December 1, 2018

Study Completion (ANTICIPATED)

December 1, 2019

Study Registration Dates

First Submitted

May 12, 2016

First Submitted That Met QC Criteria

May 12, 2016

First Posted (ESTIMATE)

May 13, 2016

Study Record Updates

Last Update Posted (ACTUAL)

August 11, 2017

Last Update Submitted That Met QC Criteria

August 9, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18882

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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