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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active study product | Active Comparator | 400 mg of Magnesium Oxide and 400 mg Riboflavin in capsule formation |
|
| Placebo study product | Placebo Comparator | Inert placebo in capsule formation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| magnesium and riboflavin supplement | Drug | Five capsules considered one dose of the intervention (one 400 mg magnesium capsule and four 100 mg riboflavin capsules) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Headache Intensity and Duration | t-test of mean differences between the groups | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stephanie Hartman, MD | Contact | 434-924-5362 | slm8nh@virginia.edu | |
| Karen Ahern, BSN MBA | Contact | 4340924-1549 | kaa7p@virginia.edu |
| Name | Affiliation | Role |
|---|---|---|
| Stephanie Hartman, MD | UVA Student Health and Wellness | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia Student Health and Wellness Center | Recruiting | Charlottesville | Virginia | 22903 | United States |
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| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| D006261 | Headache |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D008274 | Magnesium |
| ID | Term |
|---|---|
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D019565 | Metals, Light |
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| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008670 |
| Metals |