Melatonin in Acute Stroke

NCT03843008 | Withdrawn

• 1 other identifier: IRB201801934
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke, Acute; Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Melatonin Group

EXPERIMENTAL

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

No Melatonin Group

NO INTERVENTION

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

Interventions

Melatonin DIETARY_SUPPLEMENT

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.

Also known as: Nature Made melatonin, N-acetyl-5-methoxytryptamine

Melatonin Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Prisoners
• Patients with severe cognitive impairment and/or aphasia (if no family member is available to sign consent)
• Recent (\<1 month) infection
• Pregnant females

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida College of Medicine-Jacksonville

Jacksonville, Florida, 32209, United States

Location

MeSH Terms

Conditions

Stroke; Ischemic Stroke

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Andreja Packard, MD, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: At discharge, the patient will be assessed via a blinded-physician for NIHSS and this value will be recorded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 13, 2019
• First Posted: February 15, 2019
• Study Start: April 1, 2022
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: January 26, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)