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Magnesium and Riboflavin for Concussion-Related Headaches

Phase 2
Recruiting
Led By Stephanie Hartman, MD
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Able to swallow capsules
Be between 18 and 65 years old
Must not have
Taking tetracycline, fluoroquinolone, iron digoxin, chlorpromazine or penicillamine
Concussion complicated by cranial bleed, skull fracture, additional severe injury
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 days

Summary

This trial will investigate whether magnesium and riboflavin supplements can help reduce headache pain and duration in individuals with a concussion. Participants will be randomly assigned to take either the active supplements or placebo capsules once

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects from magnesium may include stomach upset or diarrhea, while riboflavin could potentially cause urine discoloration; however, both are generally considered safe at recommended doses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can swallow pills.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently taking medication such as tetracycline or fluoroquinolone.
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I had a concussion with a serious head injury.
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I am not pregnant or breastfeeding.
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I have kidney problems.
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I have major issues with my digestive system.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Headache Intensity and Duration

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Active study productActive Control1 Intervention
400 mg of Magnesium Oxide and 400 mg Riboflavin in capsule formation
Group II: Placebo study productPlacebo Group1 Intervention
Inert placebo in capsule formation

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor
782 Previous Clinical Trials
1,315,594 Total Patients Enrolled
Stephanie Hartman, MDPrincipal InvestigatorUVA Student Health and Wellness
~2 spots leftby Dec 2024
Unbiased ResultsWe believe in providing patients with all the options.
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