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Melatonin in Acute Stroke

Sponsor
University of Florida (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT03843008
Collaborator
(none)
45
Enrollment
1
Location
2
Arms
9
Anticipated Duration (Months)
5
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Melatonin
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Patients will receive 3mg of melatonin or no melatonin for up to seven days or for the duration of his or hospital stay for a maximum total of 21mg of melatonin.Patients will receive 3mg of melatonin or no melatonin for up to seven days or for the duration of his or hospital stay for a maximum total of 21mg of melatonin.
Masking:
Double (Participant, Investigator)
Masking Description:
At discharge, the patient will be assessed via a blinded-physician for NIHSS and this value will be recorded.
Primary Purpose:
Treatment
Official Title:
Role of Melatonin in the Acute Phase of Stroke as Measured by Interleukin 6 Biomarker
Anticipated Study Start Date :
Apr 1, 2022
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Melatonin Group

Participants will receive 3mg of melatonin at 18:00 (+/- one hour) each evening up to seven days or for the duration of his or her hospital stay.

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.
Other Names:
  • Nature Made melatonin
  • N-acetyl-5-methoxytryptamine

    		•
    No Intervention: No Melatonin Group

    Participants will receive no melatonin for the length of their hospital stay.

    Outcome Measures

    Primary Outcome Measures

    1. Change in serum Interleukin 6 (IL 6) [Baseline, Week 1]

      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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Florida College of Medicine-Jacksonville Jacksonville Florida United States 32209

    Sponsors and Collaborators

    • University of Florida

    Investigators

    • Principal Investigator: Andreja Packard, MD, PhD, University of Florida

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Florida
    ClinicalTrials.gov Identifier:
    NCT03843008
    Other Study ID Numbers:
    • IRB201801934
    First Posted:
    Feb 15, 2019
    Last Update Posted:
    Feb 4, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Stroke
    Ischemic Stroke
    Melatonin

    Study Results

    No Results Posted as of Feb 4, 2022