Concussion, Intermediate
Conditions
Keywords
Concussion; Headache
Brief summary
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
DRUGmagnesium and riboflavin supplement
Five capsules considered one dose of the intervention (one 400 mg magnesium capsule and four 100 mg riboflavin capsules)
Sponsors
University of Virginia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Headache Intensity and Duration | 14 days | t-test of mean differences between the groups |
Countries
United States
Contacts
Primary ContactStephanie Hartman, MD
Backup ContactKaren Ahern, BSN MBA
Outcome results
None listed