<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02235337</url>
  </required_header>
  <id_info>
    <org_study_id>17406</org_study_id>
    <nct_id>NCT02235337</nct_id>
  </id_info>
  <brief_title>The Impact of Riboflavin on the Severity and Duration of Sports Related Concussion</brief_title>
  <official_title>The Impact of Riboflavin on the Severity and Duration of Sports Related Concussion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Virginia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>James Madison University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Virginia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the effectiveness of riboflavin to decrease the&#xD;
      duration of time for a student-athlete to return to participation in sports after a sports&#xD;
      related concussion.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">August 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to return to full participation in sports after a sports related concussion</measure>
    <time_frame>21 days or less</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">248</enrollment>
  <condition>Sports Related Concussion</condition>
  <arm_group>
    <arm_group_label>Riboflavin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Riboflavin 400mg daily</intervention_name>
    <arm_group_label>Riboflavin</arm_group_label>
    <other_name>Vitamin B2</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All UVa and JMU student-athletes over the age of 18 years old who are diagnosed with a&#xD;
             sports related concussion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Less than 18 years old&#xD;
&#xD;
          -  Greater than 24 hours have elapsed since the concussion occurred.&#xD;
&#xD;
          -  The student-athlete has already participated in the study during which he/she took&#xD;
             Riboflavin&#xD;
&#xD;
          -  Non-sports related concussion not incurred while participating in the sport or&#xD;
             training for the sport. As an example, a student-athlete who sustains a concussion as&#xD;
             a result of a motor vehicle accident will be excluded from the study for that&#xD;
             concussion&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Virginia</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22908</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>James Madison University</name>
      <address>
        <city>Harrisonburg</city>
        <state>Virginia</state>
        <zip>22807</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>16716831</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>17453754</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>16983222</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>18984840</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>15447697</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>23541595</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>23248582</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>9484373</PMID>
  </reference>
  <reference>
    <citation>Sundaram U. Regulation of intestinal vitamin B(2) absorption. Focus on &quot;Riboflavin uptake by human-derived colonic epithelial NCM460 cells&quot;. Am J Physiol Cell Physiol. 2000 Feb;278(2):C268-9. doi: 10.1152/ajpcell.2000.278.2.C268. No abstract available.</citation>
    <PMID>10666021</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>23531891</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>9932987</PMID>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>September 4, 2014</study_first_submitted>
  <study_first_submitted_qc>September 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <last_update_submitted>August 9, 2017</last_update_submitted>
  <last_update_submitted_qc>August 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Virginia</investigator_affiliation>
    <investigator_full_name>Jeremy Kent, MD</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Concussion</keyword>
  <keyword>Sports related concussion</keyword>
  <keyword>mTBI</keyword>
  <keyword>Vitamin B</keyword>
  <keyword>Riboflavin</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Riboflavin</mesh_term>
  </intervention_browse>
  <pending_results>
    <submitted>April 17, 2019</submitted>
    <returned>May 6, 2019</returned>
    <submitted>October 10, 2020</submitted>
    <submission_canceled>October 10, 2020</submission_canceled>
    <submitted>October 11, 2020</submitted>
    <returned>October 13, 2020</returned>
    <submitted>December 31, 2020</submitted>
    <returned>December 31, 2020</returned>
    <submitted>December 31, 2020</submitted>
    <returned>January 6, 2021</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02235337
org study id: 17406
nct id: NCT02235337
lead sponsor: 
collaborator: 
has dmc: No
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Time to return to full participation in sports after a sports related concussion
time frame: 21 days or less
arm group label: Riboflavin
arm group type: Experimental
intervention type: Drug
intervention name: Riboflavin 400mg daily
arm group label: Riboflavin
other name: Vitamin B2
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
country: United States
citation: 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.
PMID: 16716831
citation: 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.
PMID: 17453754
citation: 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.
PMID: 16983222
citation: 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.
PMID: 18984840
citation: 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.
PMID: 15447697
citation: 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.
PMID: 23541595
citation: 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.
PMID: 23248582
citation: 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.
PMID: 9484373
citation: 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.
PMID: 10666021
citation: 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.
PMID: 23531891
citation: 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.
PMID: 9932987
responsible party type: Principal Investigator
investigator affiliation: University of Virginia
investigator full name: Jeremy Kent, MD
investigator title: Assistant Professor
mesh term: Riboflavin
submitted: April 17, 2019
returned: May 6, 2019
submitted: October 10, 2020
submission canceled: October 10, 2020
submitted: October 11, 2020
returned: October 13, 2020
submitted: December 31, 2020
returned: December 31, 2020
submitted: December 31, 2020
returned: January 6, 2021