RecruitingPhase 2NCT06260072

Magnesium and Riboflavin Treatment for Post-Concussion Headache


Sponsor

University of Virginia

Enrollment

108 participants

Start Date

Feb 10, 2020

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 40 Years

Inclusion Criteria3

  • 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 Criteria7

  • 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

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Interventions

DRUGmagnesium and riboflavin supplement

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


Locations(1)

University of Virginia Student Health and Wellness Center

Charlottesville, Virginia, United States

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NCT06260072


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