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Sports Related ConcussionNCT02235337

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

A study testing Riboflavin 400mg daily in people with Sports Related Concussion, run by University of Virginia at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sports Related Concussion
What is being tested?
Riboflavin 400mg daily
Could I receive a placebo?
No, everyone receives an active treatment
How many people
248 participants
Where
2 sitesUnited States
Study dates
Sep 2014to Aug 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All UVa and JMU student-athletes over the age of 18 years old who are diagnosed with a sports related concussion

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of Virginia

    Charlottesville, Virginia, 22908

  • James Madison University

    Harrisonburg, Virginia, 22807

Other trials in United States

About this study

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.

Being tested
Riboflavin 400mg daily
Keywords
Concussion, Sports related concussion, mTBI, Vitamin B, Riboflavin
Medical subject headings
Brain Concussion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Riboflavin 400mg dailyDrug

    Also called Vitamin B2

Study groups in NCT02235337
Study groupRoleWhat they receive
RiboflavinExperimentalNot described
Receives: Drug: Riboflavin 400mg daily

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to return to full participation in sports after a sports related concussion

    Measured: 21 days or less

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2014 (estimated)
  2. Study startSep 2014
  3. Primary completionAug 2015
  4. Study completionAug 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
248 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02235337
Sponsor's protocol ID
17406
Status last verified
Aug 2017
First submitted
4 Sep 2014
Last updated
11 Aug 2017
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 16716831

  • 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.

    PubMed 17453754

  • Langlois JA, Rutland-Brown W, Wald MM. The epidemiology and impact of traumatic brain injury: a brief overview. J Head Trauma Rehabil. 2006 Sep-Oct;21(5):375-8. doi: 10.1097/00001199-200609000-00001.

    PubMed 16983222

  • MacLennan SC, Wade FM, Forrest KM, Ratanayake PD, Fagan E, Antony J. High-dose riboflavin for migraine prophylaxis in children: a double-blind, randomized, placebo-controlled trial. J Child Neurol. 2008 Nov;23(11):1300-4. doi: 10.1177/0883073808318053.

    PubMed 18984840

  • Maizels M, Blumenfeld A, Burchette R. A combination of riboflavin, magnesium, and feverfew for migraine prophylaxis: a randomized trial. Headache. 2004 Oct;44(9):885-90. doi: 10.1111/j.1526-4610.2004.04170.x.

    PubMed 15447697

  • McCrory P, Meeuwisse W, Aubry M, Cantu B, Dvorak J, Echemendia R, Engebretsen L, Johnston K, Kutcher J, Raftery M, Sills A, Benson B, Davis G, Ellenbogen R, Guskiewicz K, Herring SA, Iverson G, Jordan B, Kissick J, McCrea M, McIntosh A, Maddocks D, Makdissi M, Purcell L, Putukian M, Schneider K, Tator C, Turner M. Consensus statement on Concussion in Sport--the 4th International Conference on Concussion in Sport held in Zurich, November 2012. J Sci Med Sport. 2013 May;16(3):178-89. doi: 10.1016/j.jsams.2013.02.009. Epub 2013 Mar 29. No abstract available.

    PubMed 23541595

  • Patterson ZR, Holahan MR. Understanding the neuroinflammatory response following concussion to develop treatment strategies. Front Cell Neurosci. 2012 Dec 12;6:58. doi: 10.3389/fncel.2012.00058. eCollection 2012.

    PubMed 23248582

  • Schoenen J, Jacquy J, Lenaerts M. Effectiveness of high-dose riboflavin in migraine prophylaxis. A randomized controlled trial. Neurology. 1998 Feb;50(2):466-70. doi: 10.1212/wnl.50.2.466.

    PubMed 9484373

  • Sundaram U. Regulation of intestinal vitamin B(2) absorption. Focus on "Riboflavin uptake by human-derived colonic epithelial NCM460 cells". Am J Physiol Cell Physiol. 2000 Feb;278(2):C268-9. doi: 10.1152/ajpcell.2000.278.2.C268. No abstract available.

    PubMed 10666021

  • Trojian TH, Jackson E. Omega-3 polyunsaturated fatty acids and concussions: treatment or not? Curr Sports Med Rep. 2011 Jul;10(4):180-5. doi: 10.1249/JSR.0b013e31822458d5. No abstract available.

    PubMed 23531891

  • Yee AJ. Effectiveness of high-dose riboflavin in migraine prophylaxis. Neurology. 1999 Jan 15;52(2):431-2. doi: 10.1212/wnl.52.2.431-a. No abstract available.

    PubMed 9932987

Questions about this trial

What is this clinical trial studying?

A study testing Riboflavin 400mg daily in people with Sports Related Concussion, run by University of Virginia at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to return to full participation in sports after a sports related concussion (time frame: 21 days or less). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02235337, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2017.

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