Magnesium and Riboflavin Treatment for Post-Concussion Headache

University of Virginia

Status and phase: Enrolling; Phase 2

Conditions: Concussion, Intermediate

Treatments: Drug: magnesium and riboflavin supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT06260072

IRB-HSR 21920

Details and patient eligibility

About

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.

Enrollment: 108 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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108 participants in 2 patient groups, including a placebo group

Active study product

Active Comparator group

Description:

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

Treatment:

Drug: magnesium and riboflavin supplement

Placebo study product

Placebo Comparator group

Description:

Inert placebo in capsule formation

Treatment:

Drug: magnesium and riboflavin supplement