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

Trial Summary

What is the purpose of this trial?

This clinical trial will try to determine if the supplements magnesium and riboflavin will reduce the pain and duration of headaches in persons diagnosed with a concussion. The participant will be randomized to either active magnesium and riboflavin capsules or placebo (inert) capsules. The capsules will be taken once a day for 14 days. The participant will also complete a short diary form for the 14 days and will have 3 follow up visits either by telephone or in person.

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.

What data supports the effectiveness of the drug Magnesium and Riboflavin Treatment for concussion-related headaches?

Research shows that magnesium can help relieve headaches, including migraines, and is recommended in several guidelines for headache relief. Additionally, magnesium has been shown to be neuroprotective in severe brain injuries, suggesting it might help with concussion-related headaches. ^{1 2 3 4 5}

Is magnesium and riboflavin treatment safe for humans?

Studies suggest that riboflavin (vitamin B2) is generally safe and has been used as a low-risk treatment for migraines. Magnesium is also commonly used and considered safe, especially in combination with riboflavin, for preventing migraines, including during pregnancy. ^{6 7 8 9 10}

How does the Magnesium and Riboflavin treatment for concussion-related headaches differ from other treatments?

This treatment is unique because it combines magnesium and riboflavin, which are known to help with migraines by improving energy efficiency in brain cells and reducing headache frequency. Unlike standard pain medications, this approach targets the underlying energy metabolism in the brain, potentially offering a novel way to manage concussion-related headaches. ^{3 6 11 12 13}

Research Team

Stephanie Hartman, MD

Principal Investigator

UVA Student Health and Wellness

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

A randomized cohort study of the efficacy of PO magnesium in the treatment of acute concussions in adolescents. [2021]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Headaches and Magnesium: Mechanisms, Bioavailability, Therapeutic Efficacy and Potential Advantage of Magnesium Pidolate. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

A combination of riboflavin, magnesium, and feverfew for migraine prophylaxis: a randomized trial. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Role of magnesium in the pathogenesis and treatment of migraines. [2013]

5. England pubmed.ncbi.nlm.nih.gov

Role of magnesium in the pathogenesis and treatment of migraine. [2013]

6. United States pubmed.ncbi.nlm.nih.gov

Evidenced-based use of botanicals, minerals, and vitamins in the prophylactic treatment of migraines. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Nutritional intake of riboflavin (vitamin B2) and migraine: a cross-sectional analysis of the National Health and Nutrition Examination Survey (NHANES) 2001-2004. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Medium-dose riboflavin as a prophylactic agent in children with migraine: a preliminary placebo-controlled, randomised, double-blind, cross-over trial. [2022]

9. Germany pubmed.ncbi.nlm.nih.gov

Assessing the efficacy of magnesium oxide and riboflavin as preventative treatment of migraines in pregnancy. [2023]

10. Iran pubmed.ncbi.nlm.nih.gov

Prophylactic effect of riboflavin on pediatric migraine: a randomized, double-blind, placebo-controlled trial. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Improvement of migraine symptoms with a proprietary supplement containing riboflavin, magnesium and Q10: a randomized, placebo-controlled, double-blind, multicenter trial. [2022]

12. England pubmed.ncbi.nlm.nih.gov

High-dose riboflavin as a prophylactic treatment of migraine: results of an open pilot study. [2017]

13. England pubmed.ncbi.nlm.nih.gov

Prophylaxis of migraine headaches with riboflavin: A systematic review. [2018]