Magnesium and Riboflavin Treatment for Post-Concussion Headache

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
University of Virginia
Study ID
NCT06260072
Phase
PHASE2
Status
Recruiting
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Conditions

  • Concussion, Intermediate

Eligibility Criteria

Sex
ALL
Age
18 Years - 40 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Feb 10, 2020
Status verified
Mar 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
108 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Active study product
    400 mg of Magnesium Oxide and 400 mg Riboflavin in capsule formation
  • Placebo Comparator: Placebo study product
    Inert placebo in capsule formation

Primary Outcome Measure

Headache Intensity and Duration [ Time Frame: 14 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Virginia Student Health and Wellness CenterCharlottesvilleVirginia22903
Karen Ahern, BSN MBA
[email protected]
434-924-1549

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By research site
University of Virginia Student Health and Wellness Center· Charlottesville, VA

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