The Impact of Riboflavin on the Severity and Duration of... | NCT02235337

Studies
The Impact of Riboflavin on the Severity and Duration of Sports Related Concussion

NCT02235337

Sponsor

University of Virginia

Status

Completed

Last Update Posted

Aug 11, 2017Actual

Enrollment

248Actual

Phase

Not Applicable

Conditions

Sports Related Concussion

Interventions

Riboflavin 400mg daily

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2014

Primary Completion Date

Aug 2015Actual

Completion Date

Aug 2015Actual

First Submitted Date

Sep 4, 2014

First Submission Date that Met QC Criteria

Sep 8, 2014

First Posted Date

Sep 9, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 9, 2017

Last Update Posted Date

Aug 11, 2017Actual

Name	Class
James Madison University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

248Actual

Label	Type	Description	Intervention Names
Riboflavin	Experimental		Drug: Riboflavin 400mg daily

Name	Type	Description	Arm Group Labels	Other Names
Riboflavin 400mg daily	Drug		Riboflavin	Vitamin B2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to return to full participation in sports after a sports related concussion		21 days or less

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Virginia		Charlottesville	Virginia	22908	United States
James Madison University

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16716831	Background	Barbre AB, Hoane MR. Magnesium and riboflavin combination therapy following cortical contusion injury in the rat. Brain Res Bull. 2006 May 31;69(6):639-46. doi: 10.1016/j.brainresbull.2006.03.009. Epub 2006 Apr 3.
17453754	Background	Kokiko ON, Hamm RJ. A review of pharmacological treatments used in experimental models of traumatic brain injury. Brain Inj. 2007 Mar;21(3):259-74. doi: 10.1080/02699050701209964.

Type	Date	Date Unknown
Release	Apr 17, 2019
Reset	May 6, 2019
Release	Oct 10, 2020
Unrelease	Oct 10, 2020
Release	Oct 11, 2020
Reset	Oct 13, 2020
Release	Dec 31, 2020
Reset	Dec 31, 2020
Release	Dec 31, 2020
Reset	Jan 6, 2021

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Apr 17, 2019			May 6, 2019
Oct 10, 2020	Oct 10, 2020

ID	Term
D000070642	Brain Injuries, Traumatic
D001930	Brain Injuries
D001927	Brain Diseases
D002493	Central Nervous System Diseases

ID	Term
D005415	Flavins
D011621	Pteridines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring