Magnesium and Riboflavin Treatment for Post-Concussion Headache

Phase 2

Recruiting

• Conditions: Concussion, Intermediate
• Interventions: Drug: magnesium and riboflavin supplement

• Registration Number: NCT06260072
• Lead Sponsor: University of Virginia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-10
• Study First Submitted: 2024-02-06
• Study First Submitted QC: 2024-02-06
• Study First Posted: 2024-02-15
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-27
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 108

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo study product	magnesium and riboflavin supplement	Inert placebo in capsule formation
Active study product	magnesium and riboflavin supplement	400 mg of Magnesium Oxide and 400 mg Riboflavin in capsule formation

Primary Outcome Measures

Name	Time	Method
Headache Intensity and Duration	14 days	t-test of mean differences between the groups

Trial Locations

Locations (1)

University of Virginia Student Health and Wellness Center; 🇺🇸 Charlottesville, Virginia, United States