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Melatonin Supplement

Melatonin for Cardiovascular Response to Stress

Phase 4
Recruiting
Led By Jeremy M Kellawan
Research Sponsored by University of Oklahoma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Must not have
Sex hormone replacement medical use (e.g. testosterone, estrogen, progesterone)
Regular melatonin use >= 1 use/week
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 minutes of rest and 7 minutes of exercise
Awards & highlights

Summary

This trial is testing if taking melatonin can change how the heart and blood vessels respond to cold and exercise in healthy people. Melatonin might help manage stress on the heart and blood vessels by calming the nervous system. Melatonin has been shown to influence the cardiovascular system by reducing blood pressure, altering nerve activity, and affecting blood vessel function.

Who is the study for?
This trial is for healthy men and women, specifically premenopausal women with regular menstrual cycles. It excludes those on cardiometabolic meds, with high blood pressure or diabetes, using sex hormone replacements or tobacco products, pregnant individuals, people with a history of autonomic dysfunction, cardiovascular diseases, allergies to melatonin or regular users of melatonin.
What is being tested?
The study aims to see if taking melatonin once can change how the heart and blood vessels respond to stress from cold exposure at rest and during exercise. Participants will be randomly given either melatonin or a placebo (a dummy pill) to compare effects.
What are the potential side effects?
Melatonin may cause drowsiness, mild headache, sleepiness or grogginess upon waking. Since it's generally considered safe for short-term use in healthy individuals; serious side effects are rare.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am using sex hormone replacement therapy.
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I use melatonin regularly, at least once a week.
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I have diabetes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 minutes of rest and 7 minutes of exercise
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 minutes of rest and 7 minutes of exercise for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mean Arterial Pressure
Muscle Tissue Oxygenation
Secondary study objectives
Cardiac Output
Cerebral Oxygenation
Heart Rate
+4 more

Side effects data

From 2017 Phase 3 trial • 709 Patients • NCT00668707
16%
Fatgiue
11%
Insomnia
10%
Death
9%
Nausea
9%
Dyspnea
8%
Diarrhea
5%
Postoperative Pain
4%
Constipation
4%
Cough
3%
Vomiting
3%
Peripheral Neuropathy
3%
Headache
3%
Neutropenia
2%
Appetite changes
2%
Air Leak
2%
Dizziness
2%
Chest pain
2%
Cold/Flu Symptoms
1%
New Neoplasm
1%
Pneumonia
1%
Pneumothorax
1%
Pulmonary embolism
1%
Anemia
1%
Acid reflux
1%
Flatulence
1%
GERD
1%
Weight loss
1%
Gall bladder attack
1%
Back pain
1%
Syncope
1%
Vertigo
1%
Bonchitis
1%
New Neoplasm - Lung Cancer
1%
Tinnitus
1%
Anorexia
1%
Anxiety
1%
Depression
1%
Subcutaneous Emphysema
1%
dry mouth
1%
Erythema
1%
Epistaxis
1%
Pruritis
1%
Rash
1%
Prolonged Air Leak
1%
Hyperglycemia
1%
Thrush (mouth)
1%
Hip replacement surgery
1%
Atrial fibrillation
1%
Indigestion
1%
Peripheral Edema
1%
C-Difficile
1%
Surgical site infection
1%
Fall
1%
Pain
1%
Radiation pneumonitis
1%
Surgical Site Pain
1%
Dry Cough
1%
Pleural effusion
1%
Hypertension
1%
Tachycardia
1%
Dysphagia
1%
Sinus infection
1%
Myalgia
1%
Hearing loss
1%
Hemoptysis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Melatonin
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: MelatoninExperimental Treatment1 Intervention
5mg commercially available melatonin (MEL) spray will be given sublingually.
Group II: PlaceboPlacebo Group1 Intervention
Placebo (PLA) is 10 sublingual sprays of a diluted (1 microliter/29ml filtered water) mint extract.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
melatonin
2013
Completed Phase 3
~2260

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Melatonin, commonly used in healthy subjects, acts primarily as an antioxidant and a chronobiotic agent. It helps regulate circadian rhythms, which are essential for maintaining consistent sleep-wake cycles and overall bodily functions. By improving sleep quality and synchronizing internal clocks, melatonin enhances overall health and well-being. Its antioxidant properties also help reduce oxidative stress, preventing cellular damage and supporting long-term health.

Find a Location

Who is running the clinical trial?

University of OklahomaLead Sponsor
467 Previous Clinical Trials
91,213 Total Patients Enrolled
Jeremy M KellawanPrincipal InvestigatorUniversity of Oklahoma

Media Library

Melatonin (Melatonin Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT04831398 — Phase 4
Healthy Subjects Research Study Groups: Placebo, Melatonin
Healthy Subjects Clinical Trial 2023: Melatonin Highlights & Side Effects. Trial Name: NCT04831398 — Phase 4
Melatonin (Melatonin Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04831398 — Phase 4
~36 spots leftby Oct 2025