The Impact of Riboflavin on Sports-related Concussion | NCT02772237

Studies
The Impact of Riboflavin on Sports-related Concussion

NCT02772237

Sponsor

University of Virginia

Status

Unknown status

Last Update Posted

Aug 11, 2017Actual

Enrollment

500Estimated

Phase

Phase 2

Conditions

Sports-related Concussion

Interventions

Riboflavin
Placebo

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

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2016

Primary Completion Date

Dec 2018Estimated

Completion Date

Dec 2019Estimated

First Submitted Date

May 12, 2016

First Submission Date that Met QC Criteria

May 12, 2016

First Posted Date

May 13, 2016Estimated

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

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment group	Active Comparator	Riboflavin 400mg daily	Biological: Riboflavin
Placebo group	Placebo Comparator	Placebo	Biological: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Riboflavin	Biological	Riboflavin 400mg daily	Treatment group	Vitamin B2

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

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.
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.

Accepts Healthy Volunteers

Yes

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

Name	Role	Phone	Extension	Email
Jeremy Kent, MD	Contact	434-924-1165
Kent Diduch, MD	Contact

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Virginia	Recruiting	Charlottesville	Virginia	22904	United States

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	Oct 10, 2020
Unrelease	Oct 10, 2020
Release	Oct 30, 2020
Reset	Nov 19, 2020
Release	Dec 31, 2020
Reset	Jan 20, 2021

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Oct 10, 2020	Oct 10, 2020
Oct 30, 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