Melatonin in Acute Stroke

Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03843008
• Other study ID #: IRB201801934
• Status: Withdrawn
• Phase: N/A
• Start date: April 2022
• Est. completion date: January 2023

Study information

• Verified date: January 2024
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2023
• Est. primary completion date: January 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Adult patients admitted to the Neuroscience Critical Care Unit with a confirmed ischemic stroke

• Patients with a clinical history and examination consistent with an ischemic stroke (stroke must be confirmed by a brain CT and/or MRI scan)

• Eligible patients will have been treated with TPA and/or thrombectomy.

Exclusion Criteria:

• Prisoners

• Patients with severe cognitive impairment and/or aphasia (if no family member is available to sign consent)

• Recent (<1 month) infection

• Pregnant females

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke
• Stroke, Acute

Intervention

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.

Locations

Country	Name	City	State
United States	University of Florida College of Medicine-Jacksonville	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in serum Interleukin 6 (IL 6)	Determine whether Interleukin 6 (IL-6) is lowered after the administration of melatonin. At 6:00 (+/- one hour) each morning for the duration of the hospital stay, patient will have IL-6 biomarker assayed. This testing will continue for the duration of the hospital stay, or for seven days (whichever comes first).	Baseline, Week 1