Magnesium and Riboflavin Treatment for Post-Concussion Headache

Last updated: March 24, 2025
Sponsor: University of Virginia
Overall Status: Active - Recruiting

Phase

2

Condition

Chronic Pain

Brain Injury

Pain (Pediatric)

Treatment

magnesium and riboflavin supplement

Clinical Study ID

NCT06260072
IRB-HSR 21920
  • Ages 18-40
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Seen at University of Virginia Student Health and Wellness Center or EmergencyDepartment for Initial Visit for Concussion;

  • Less than 3 days have elapsed since their injury;

  • Able to swallow capsules

Exclusion

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

Study Design

Total Participants: 108
Treatment Group(s): 1
Primary Treatment: magnesium and riboflavin supplement
Phase: 2
Study Start date:
February 10, 2020
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • University of Virginia Student Health and Wellness Center

    Charlottesville, Virginia 22903
    United States

    Active - Recruiting

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