Magnesium and Riboflavin for Concussion-Related Headaches

Overseen By Karen Ahern, BSN MBA

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Virginia

Must not be taking: Tetracycline, Fluoroquinolone, others

Disqualifiers: Cranial bleed, Kidney dysfunction, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 2 weeks

108 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if magnesium and riboflavin (a type of vitamin B) can reduce the pain and duration of headaches caused by concussions. Participants will randomly receive either the active supplement capsules or placebo capsules once a day for 14 days. Ideal candidates are individuals who have experienced a concussion in the last three days and have visited the University of Virginia Student Health and Wellness Center or Emergency Department. Participants must also complete a short diary for two weeks and attend three follow-up visits. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking tetracycline, fluoroquinolone, iron digoxin, chlorpromazine, or penicillamine.

Is there any evidence suggesting that magnesium and riboflavin are likely to be safe for humans?

Research shows that magnesium and riboflavin (vitamin B2) are generally safe and often used to treat migraines. Studies have found that riboflavin poses low risk, typically causing few side effects. Magnesium, commonly used in similar treatments, is considered safe at the dose used in this trial.

Experts agree that short-term use of these supplements can be effective and is usually well-tolerated. Although no treatment is entirely risk-free, existing evidence suggests that using magnesium and riboflavin together safely helps relieve headaches in people with concussions. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for concussion-related headaches?

Researchers are excited about using magnesium and riboflavin for concussion-related headaches because these nutrients offer a fresh approach to treatment. Unlike conventional medications that primarily focus on pain relief, magnesium and riboflavin may help by addressing underlying biochemical factors that contribute to headaches. Magnesium is believed to stabilize nerve cell membranes and reduce inflammation, while riboflavin, a form of vitamin B2, plays a crucial role in energy production within cells. This combination could potentially provide a more natural and holistic way to manage headaches following a concussion.

What evidence suggests that magnesium and riboflavin might be an effective treatment for concussion-related headaches?

Research has shown that magnesium and riboflavin (vitamin B2) supplements might help reduce headache pain and duration in people with concussions. The American Headache Society notes these supplements could benefit young people recovering from concussions. One study found that taking 400 mg of riboflavin daily for two weeks shortened recovery time for sports-related concussions. Another report indicated that 70% of patients experienced some improvement in their headaches with similar treatments. In this trial, participants will receive either an active study product containing 400 mg of Magnesium Oxide and 400 mg of Riboflavin or a placebo. These early findings suggest that magnesium and riboflavin might effectively ease headaches related to concussions. ^{1 2 3 4 6}

Who Is on the Research Team?

Stephanie Hartman, MD

Principal Investigator

UVA Student Health and Wellness

Are You a Good Fit for This Trial?

This trial is for individuals who have been diagnosed with a concussion and are experiencing headaches. Participants will take capsules daily for two weeks and keep a diary of their headache symptoms. They must be available for three follow-up visits or calls.

Inclusion Criteria

Seen at University of Virginia Student Health and Wellness Center or Emergency Department for Initial Visit for Concussion

My injury occurred within the last 3 days.

I can swallow pills.

Exclusion Criteria

Two or more previous concussions

I am currently taking medication such as tetracycline or fluoroquinolone.

I had a concussion with a serious head injury.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either active magnesium and riboflavin capsules or placebo capsules once a day for 14 days

2 weeks

Daily self-administration, 3 follow-up visits (telephone or in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Magnesium and Riboflavin Treatment

Trial Overview The study is testing whether magnesium and riboflavin supplements can help reduce the pain and frequency of post-concussion headaches compared to placebo capsules, which have no active ingredients.

How Is the Trial Designed?

Group I: Active study product Active Control 1 Intervention

400 mg of Magnesium Oxide and 400 mg Riboflavin in capsule formation

Group II: Placebo study product Placebo Group 1 Intervention

Inert placebo in capsule formation

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials

802

Recruited

1,342,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06260072

Magnesium and Riboflavin Treatment for Post-Concussion ... It identifies the role of the intervention that participants receive. Types of arms include experimental arm, active comparator arm, placebo comparator arm, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11694339/

American Headache Society white paper on treatment of post ... Supplements including magnesium, riboflavin, and melatonin have shown promise in aiding concussion recovery in youth and young adults. Nightly ...

3. withpower.com withpower.com/trial/phase-2-brain-concussion-1-2020-031eb?condition=&query=Riboflavin&overallStatus=Recruiting&hasNoPlacebo=false

Magnesium and Riboflavin for Concussion-Related ... Trial Overview The study is testing whether magnesium and riboflavin supplements can help reduce the pain and frequency of post-concussion headaches compared to ...

4. headachejournal.onlinelibrary.wiley.com headachejournal.onlinelibrary.wiley.com/doi/10.1111/head.14795

American Headache Society white paper on treatment of post ... Overall, 70% of patients reported at least some improvement in headache, but response to treatment was not stratified by headache type. Until ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12048115/

Dietary supplementation roles in concussion management Kent et al. reported that 400 mg of daily riboflavin for 2 weeks reduced recovery time in sport-related concussions occurred within 24 h (9.92 ...

6. thejournalofheadacheandpain.biomedcentral.com thejournalofheadacheandpain.biomedcentral.com/articles/10.1186/s10194-020-01122-5

Persistent post-traumatic headache: a migrainous loop or not ... Magnesium may be effective as a prophylactic treatment with 400 mg daily of chelated magnesium, magnesium oxide or slow-release magnesium in ...