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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:Select...
I am using sex hormone replacement therapy.
Select...
I use melatonin regularly, at least once a week.
Select...
I have diabetes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7 minutes of rest and 7 minutes of exercise
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 minutes of rest and 7 minutes of exercise
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 moreSide effects data
From 2017 Phase 3 trial • 709 Patients • NCT0066870716%
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a healthy man or woman.You use tobacco or nicotine products.I am using sex hormone replacement therapy.You are allergic to melatonin.I am taking medication for heart health or diabetes.You have a history of problems with your body's automatic functions (like heart rate or digestion).I use melatonin regularly, at least once a week.You are pregnant.I am a premenopausal woman with a regular menstrual cycle.I have diabetes.I have a heart condition.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Melatonin
Awards:
This trial has 2 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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