Magnesium and Riboflavin for Concussion-Related Headaches

Palo Alto (17 mi)

Overseen byStephanie Hartman, MD

Age: 18 - 65

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: University of Virginia

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for individuals who have been diagnosed with a concussion and are experiencing headaches. Participants will take capsules daily for two weeks and keep a diary of their headache symptoms. They must be available for three follow-up visits or calls.

Inclusion Criteria

I can swallow pills.

Exclusion Criteria

I am currently taking medication such as tetracycline or fluoroquinolone.

I had a concussion with a serious head injury.

I am not pregnant or breastfeeding.

I have kidney problems.

I have major issues with my digestive system.

Treatment Details

The study is testing whether magnesium and riboflavin supplements can help reduce the pain and frequency of post-concussion headaches compared to placebo capsules, which have no active ingredients.

2Treatment groups

Active Control

Placebo Group

Group I: Active study productActive Control1 Intervention

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

Group II: Placebo study productPlacebo Group1 Intervention

Inert placebo in capsule formation