NCT03843008

Melatonin in Acute Stroke

Role of Melatonin in the Acute Phase of Stroke as Measured by Interleukin 6 Biomarker

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study will measure Interleukin 6 (IL-6), a well-documented inflammatory biomarker that is increased in the acute phase of stroke, and to compare its levels after the administration of melatonin - a well-documented anti-inflammatory and anti-oxidant - that regulates circadian rhythm, which helps promote sleep.

Detailed description

Stroke is a major cause of debilitation in the first world, with few therapeutic options when it comes to improvement in quality of life and morbidity, besides physical and occupational therapy. It affects people of all nationalities, creeds, and socioeconomic classes through a narrow array of mechanisms. With all those mechanisms, a common outcome is shared: derangement of the brain parenchymal architecture. This derangement is non-selective in its destruction with obscuration of the blood brain barrier and the glymphatic system, and with bleeding as a common sequela; the oxidative stress of the hemoglobin-heme-iron compound causing further injury. This study will measure Interleukin 6 (IL-6), a well-documented inflammatory biomarker that is increased in the acute phase of stroke, and to compare its levels after the administration of melatonin - a well-documented anti-inflammatory and anti-oxidant - that regulates circadian rhythm, which helps promote sleep. Any increased time spent in a restful state because of melatonin increases the clearance of waste products after a catastrophic event, like in stroke.

Conditions

• Stroke, Acute
• Ischemic Stroke

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Melatonin	Participants in the Melatonin Group will receive 3mg of melatonin each evening for up to seven days for a maximum total of 21mg of melatonin.

Timeline

• Start date: 2022-04-01
• Primary completion: 2023-01-01
• Completion: 2023-01-01
• First posted: 2019-02-15
• Last updated: 2024-01-26

Locations

1 site across 1 country: United States