Sports-related ConcussionPhase 2NCT02772237
The Impact of Riboflavin on Sports-related Concussion
A Phase 2 study testing Riboflavin in people with Sports-related Concussion, run by University of Virginia at 1 site in United States.
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 olderHealthy volunteers can take part
- Conditions the study is for
- Sports-related Concussion
- What is being tested?
- Riboflavin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Dec 2019
- Phase
- Phase 2
- 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
- Healthy volunteers accepted
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
Jeremy Kent, MD contact
Kent Diduch, MD contact
United States1 site, 1 recruiting
- Recruiting
University of Virginia
Charlottesville, Virginia, 22904
Jeremy B Kent
About this study
Official title: 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.
- Conditions
- Sports-related Concussion
- Being tested
- Riboflavin, Placebo
- Keywords
- concussion, sports-related concussion, mTBI, Riboflavin, Vitamin B2
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RiboflavinBiological
Also called Vitamin B2
Riboflavin 400mg daily
PlaceboBiological
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Active comparator | Riboflavin 400mg daily Receives: Biological: Riboflavin |
| Placebo group | Placebo comparator | Placebo Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to return to participation in sports after a sports-related concussion
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2016 (estimated)
- Study startAug 2016
- Primary completionDec 2018 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Sports-related ConcussionStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- James Madison University
- Responsible party
- Principal investigator, Jeremy Kent, MD, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02772237
- Sponsor's protocol ID
- 18882
- Status last verified
- Aug 2017
- First submitted
- 12 May 2016
- Last updated
- 11 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- 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 16716831Kokiko 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 17453754Sorden SD, Lemanske RF Jr, Castleman WL. Pulmonary eosinophilia and granulomatous pulmonary arteritis induced in rats by intravenous Sephadex. Vet Pathol. 1990 Jul;27(4):217-22. doi: 10.1177/030098589002700401.
PubMed 1698322MacLennan 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 18984840Maizels 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 15447697McCrory 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 23541595Patterson 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 23248582Schoenen 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 9484373Sundaram 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 10666021Trojian 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 23531891Yee 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
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Riboflavin on Sports-related Concussion: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT02772237
- Acronym / sponsor ID
- 18882
- Conditions
- Sports-related Concussion
- Keywords
- concussion, sports-related concussion, mTBI, Riboflavin, Vitamin B2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- James Madison University
- Study start
- Aug 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 13 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Active comparator | Biological: RiboflavinRiboflavin 400mg daily |
| Placebo group | Placebo comparator | Biological: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All UVa and JMU student-athletes over the age of 18 years old who are diagnosed with a sports related concussion
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RiboflavinAlso: Vitamin B2Riboflavin 400mg daily | Biological | Treatment group |
| Placebo | Biological | Placebo group |
Primary outcome
Time to return to participation in sports after a sports-related concussion
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2017.
- Background: PubMed 16716831Barbre 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.
- Background: PubMed 17453754Kokiko 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.
- Background: PubMed 1698322Sorden SD, Lemanske RF Jr, Castleman WL. Pulmonary eosinophilia and granulomatous pulmonary arteritis induced in rats by intravenous Sephadex. Vet Pathol. 1990 Jul;27(4):217-22. doi: 10.1177/030098589002700401.
- Background: PubMed 18984840MacLennan 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.
- Background: PubMed 15447697Maizels 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.
- Background: PubMed 23541595McCrory 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.
- Background: PubMed 23248582Patterson 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.
- Background: PubMed 9484373Schoenen 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.
- Background: PubMed 10666021Sundaram 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.
- Background: PubMed 23531891Trojian 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.
- Background: PubMed 9932987Yee 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeremy Kent, MD contact
Kent Diduch, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Riboflavin in people with Sports-related Concussion, run by University of Virginia at 1 site 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 7 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: status not confirmed, 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 1 site 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeremy Kent, MD (434-924-1165), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to return to participation in sports after a sports-related concussion (time frame: 14 days). 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 NCT02772237, 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.