Magnesium and Riboflavin Treatment for Post-Concussion Headache

March 24, 2025 updated by: Stephanie Hartman, MD, University of Virginia
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

108

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Recruiting
        • University of Virginia Student Health and Wellness Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active study product
400 mg of Magnesium Oxide and 400 mg Riboflavin in capsule formation
Drug: magnesium and riboflavin supplement
Five capsules considered one dose of the intervention (one 400 mg magnesium capsule and four 100 mg riboflavin capsules)
Placebo Comparator: Placebo study product
Inert placebo in capsule formation
Drug: magnesium and riboflavin supplement
Five capsules considered one dose of the intervention (one 400 mg magnesium capsule and four 100 mg riboflavin capsules)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Headache Intensity and Duration
Time Frame: 14 days
t-test of mean differences between the groups
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Investigators

  • Principal Investigator: Stephanie Hartman, MD, UVA Student Health and Wellness

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2020

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

February 6, 2024

First Submitted That Met QC Criteria

February 6, 2024

First Posted (Actual)

February 15, 2024

Study Record Updates

Last Update Posted (Actual)

March 27, 2025

Last Update Submitted That Met QC Criteria

March 24, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-HSR 21920

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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