Using magnesium and riboflavin to treat headaches after a concussion
Magnesium and Riboflavin Treatment for Post-Concussion Headache
This study tests if taking magnesium and riboflavin supplements can help people with concussions feel better by reducing headache pain and how long the headaches last.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 108 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | University of Virginia Academic / other |
| Locations | 1 site (Charlottesville, Virginia) |
| Trial ID | NCT06260072 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate whether magnesium and riboflavin supplements can alleviate headache pain and reduce the duration of headaches in individuals diagnosed with a concussion. Participants will be randomly assigned to receive either the active supplements or a placebo for 14 days, taking one capsule daily. Throughout the study, participants will maintain a diary to track their symptoms and will attend three follow-up visits, either by phone or in person, to monitor their progress.
Who should consider this trial
Good fit: Ideal candidates are individuals who have recently been diagnosed with a concussion and are able to swallow capsules.
Not a fit: Patients with severe complications from their concussion, such as cranial bleed or skull fractures, will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a non-invasive option for managing post-concussion headaches.
How similar studies have performed: While the specific combination of magnesium and riboflavin for post-concussion headaches is novel, there is existing research on the individual effects of these supplements on headache management.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Seen at University of Virginia Student Health and Wellness Center or Emergency Department for Initial Visit for Concussion; * Less than 3 days have elapsed since their injury; * Able to swallow capsules Exclusion Criteria: * Concussion complicated by cranial bleed, skull fracture, additional severe injury; * Kidney disfunction or failure; * Significant gastro-intestinal dysfunction; * Varsity Athlete; * Two or more previous concussions; * Women who are pregnant or breast feeding; * Taking tetracycline, fluoroquinolone, iron digoxin, chlorpromazine or penicillamine
Where this trial is running
Charlottesville, Virginia
- University of Virginia Student Health and Wellness Center — Charlottesville, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Stephanie Hartman, MD — UVA Student Health and Wellness
- Study coordinator: Stephanie Hartman, MD
- Email: slm8nh@virginia.edu
- Phone: 434-924-5362
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.