Print Send My Information

Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 40 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
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)

Recruiting Locations

University of Virginia Student Health and Wellness Center
Charlottesville, Virginia 22903
Contact:
Karen Ahern, BSN MBA
434-924-1549
kaa7p@virginia.edu

More Details

NCT ID
NCT06260072
Status
Recruiting
Sponsor
University of Virginia

Study Contact

Stephanie Hartman, MD
434-924-5362
slm8nh@virginia.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center