Magnesium and Riboflavin Treatment for Post-Concussion Headache
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: magnesium and riboflavin supplement.
- Who it may be relevant to
- Registry conditions: Concussion, Intermediate. Basic parameters: 18 years — 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug magnesium and riboflavin supplement
Five capsules considered one dose of the intervention (one 400 mg magnesium capsule and four 100 mg riboflavin capsules)
Primary outcome measures
- Headache Intensity and Duration [Time frame: 14 days]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Virginia Student Health and Wellness Center — Charlottesville
Identifiers
NCT: NCT06260072 · IRB-HSR 21920