Recruiting
Phase 2

Magnesium & Riboflavin

Sponsor:

University of Virginia

Code:

NCT06260072

Conditions

Concussion, Intermediate

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Not accepted

Interventions

magnesium and riboflavin supplement

Study Details

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.

Conditions

Concussion, Intermediate

Study ID

NCT06260072

Start date

Feb 10, 2020

Status verified date

Mar, 2025

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Not accepted

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 Design

Enrollment

108 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Active study product

400 mg of Magnesium Oxide and 400 mg Riboflavin in capsule formation

placebo comparator: Placebo study product

Inert placebo in capsule formation

Interventions

magnesium and riboflavin supplement

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

Primary outcome measure

  • Headache Intensity and Duration [ Time Frame: 14 days ]

Central Contacts and Locations

Central contacts

Stephanie Hartman, MD

434-924-5362slm8nh@virginia.edu

Karen Ahern, BSN MBA

4340924-1549kaa7p@virginia.edu

Locations

University of Virginia Student Health and Wellness Center

Recruiting

Charlottesville, Virginia, United States, 22903

Contacts

Karen Ahern, BSN MBA

434-924-1549kaa7p@virginia.edu

More Information

Sponsor

University of Virginia

Last update posted

Mar 27, 2025

Last verified

Mar, 2025

Keywords

  • Concussion; Headache

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2025-03-27.