Magnesium and Riboflavin Treatment for Post-Concussion Headache

ConditionConcussion, Intermediate

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-40

SponsorUniversity of Virginia

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Concussion complicated by cranial bleed, skull fracture, additional severe injury;

Kidney disfunction or failure;

Significant gastro-intestinal dysfunction;

Varsity Athlete;

Trial design

Design model

Parallel

Treatments tested in this trial

magnesium and riboflavin supplement
Drug
Five capsules considered one dose of the intervention (one 400 mg magnesium capsule and four 100 mg riboflavin capsules)

Treatment groups

108 Participants

are divided into 2 treatment groups

Group A: Active study productActive comparator 1 intervention

Group B: Placebo study productPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Headache Intensity and Duration

t-test of mean differences between the groups

Time frame

14 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Virginia

Lead sponsor

Source ClinicalTrials.gov

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