NCT05065528

Mag Con: Efficacy of Oral Mag. in Acute Concussion in Adolescents

A Randomized Trial Evaluating the Efficacy of Oral Magnesium in Symptomatic Reduction of Acute Concussion in Adolescents

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Corewell Health South · Academic / Other
• Sex: All
• Age: 12 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized trial will compare the clinical efficacy of adding oral magnesium oxide to acetaminophen and ondansetron in the treatment of adolescents presenting within 48 hours of a mild traumatic brain injury using the Post-Concussion Symptom Severity Score Index.

Detailed description

This randomized trial will compare the clinical efficacy of oral magnesium oxide, acetaminophen and ondansetron, to that of PO acetaminophen and ondansetron in the treatment of adolescents presenting within 48 hours of a mild traumatic brain injury. Our primary endpoint will be to evaluate if magnesium has an impact on patient's Post-Concussion Symptom Severity Score Index. This will be evaluated both at the initial presentation in-person and then at 24, 48, and 72 hours via phone

Conditions

• Concussion, Mild
• Traumatic Brain Injury, Mild

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Magnesium	Will receive symptomatic care (ondansetron 4mg and acetaminophen 500 mg each twice daily) along with 400 mg supplemental magnesium twice daily for 3 days
DRUG	Placebo	Will receive symptomatic care (ondansetron 4mg and acetaminophen 500 mg each twice daily) along with placebo pill

Timeline

• Start date: 2021-08-30
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2021-10-04
• Last updated: 2024-11-29

Locations

1 site across 1 country: United States