Magnesium and Riboflavin Treatment for Post-Concussion Headache

NCT ID: NCT06260072

Last Updated: 2025-03-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-10
• Study Completion Date: 2025-12-31

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Active study product

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

Group Type: ACTIVE_COMPARATOR

magnesium and riboflavin supplement

Intervention Type: DRUG

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

Placebo study product

Inert placebo in capsule formation

Group Type: PLACEBO_COMPARATOR

magnesium and riboflavin supplement

Intervention Type: DRUG

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

Interventions

magnesium and riboflavin supplement

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

Stephanie Hartman, MD

Associate Director of Primary Care UVA Student Health & Wellness

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephanie Hartman, MD

Role: PRINCIPAL_INVESTIGATOR

UVA Student Health and Wellness

Locations

University of Virginia Student Health and Wellness Center

Charlottesville, Virginia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Stephanie Hartman, MD

Role: CONTACT

slm8nh@virginia.edu

434-924-5362

Karen Ahern, BSN MBA

Role: CONTACT

kaa7p@virginia.edu

4340924-1549

Facility Contacts

Karen Ahern, BSN MBA

Role: primary

kaa7p@virginia.edu

434-924-1549

Other Identifiers

IRB-HSR 21920

Identifier Type: -

Identifier Source: org_study_id