search
Back to results

Melatonin in Acute Stroke

Primary Purpose

Stroke, Acute, Ischemic Stroke

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Melatonin
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Acute

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Florida College of Medicine-Jacksonville

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Melatonin Group

No Melatonin Group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
February 13, 2019
Last Updated
February 3, 2022
Sponsor
University of Florida
search

1. Study Identification

Unique Protocol Identification Number
NCT03843008
Brief Title
Melatonin in Acute Stroke
Official Title
Role of Melatonin in the Acute Phase of Stroke as Measured by Interleukin 6 Biomarker
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 2022 (Anticipated)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
January 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Acute, Ischemic Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantInvestigator
Masking Description
At discharge, the patient will be assessed via a blinded-physician for NIHSS and this value will be recorded.
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Melatonin Group
Arm Type
Experimental
Arm Description
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.
Arm Title
No Melatonin Group
Arm Type
No Intervention
Arm Description
Participants will receive no melatonin for the length of their hospital stay.
Intervention Type
Dietary Supplement
Intervention Name(s)
Melatonin
Other Intervention Name(s)
Nature Made melatonin, N-acetyl-5-methoxytryptamine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in serum Interleukin 6 (IL 6)
Description
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).
Time Frame
Baseline, Week 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jonathan Greco, DO
Phone
904-244-9822
Email
jonathan.greco@jax.ufl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreja Packard, MD, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida College of Medicine-Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Melatonin in Acute Stroke

We'll reach out to this number within 24 hrs