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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 minutes of rest and 7 minutes of exercise
Awards & highlights
Study Summary
This trial will see if melatonin affects blood pressure in response to stressors like cold water and exercise.
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.Check my eligibility
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.See study design
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.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean Arterial Pressure
Muscle Tissue Oxygenation
Secondary outcome measures
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%
Headache
3%
Peripheral Neuropathy
3%
Neutropenia
2%
Appetite changes
2%
Air Leak
2%
Dizziness
2%
Chest pain
2%
Cold/Flu Symptoms
1%
Pneumothorax
1%
New Neoplasm - Lung Cancer
1%
Weight loss
1%
dry mouth
1%
Anorexia
1%
Anemia
1%
Pneumonia
1%
Back pain
1%
Erythema
1%
Flatulence
1%
Vertigo
1%
Bonchitis
1%
Pulmonary embolism
1%
Gall bladder attack
1%
GERD
1%
Anxiety
1%
Tinnitus
1%
Depression
1%
Syncope
1%
Acid reflux
1%
Epistaxis
1%
Pruritis
1%
Rash
1%
Prolonged Air Leak
1%
Hyperglycemia
1%
Thrush (mouth)
1%
Hip replacement surgery
1%
Subcutaneous Emphysema
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%
New Neoplasm
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
Find a Location
Who is running the clinical trial?
University of OklahomaLead Sponsor
455 Previous Clinical Trials
97,513 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What potential side-effects may arise when taking melatonin?
"The safety profile associated with melatonin is rated as a 3, due to this medication having been approved at the Phase 4 stage."
Answered by AI
Are there any new openings for participation in this trial?
"The clinicaltrials.gov database presently indicates that this medical study is not recruiting patients, even though it was first posted in January of 2023 and last updated on October 31st 2022. Fortunately, 841 other trials are currently open for enrolment."
Answered by AI
Does the eligibility for this clinical trial extend to individuals under 55 years old?
"To take part in this medical trial, individuals must be above the age of consent and below 35 years old."
Answered by AI
Am I eligible to be involved in this clinical experiment?
"To qualify for this trial, eligible patients must be hale and of age (18-35). The team is seeking to recruit an approximate total of 100 individuals."
Answered by AI
What is the primary goal of this research endeavor?
"This experiment seeks to measure Mean Arterial Pressure during a 7-minute rest period and again following 7 minutes of exercise. Secondary objectives include quantifying Cerebral Oxygenation, Heart Rate, and Stroke Volume via noninvasive methods."
Answered by AI
Who else is applying?
What state do they live in?
Oklahoma
What site did they apply to?
Department of Health and Exercise Science
What portion of applicants met pre-screening criteria?
Met criteria
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