What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Melatonin, commonly used as an antioxidant and chronobiotic agent, has been associated with mild side effects such as headaches and fatigue. In clinical trials, no significant adverse events were reported, indicating a favorable safety profile. However, as with any supplement, individual responses can vary, and it is advisable to consult with a healthcare provider before starting any new treatment.

What prior FDA approvals exist?

Ramelteon, a selective MT1/MT2 receptor agonist, has been approved by the FDA for the treatment of insomnia. It functions similarly to melatonin by binding to melatonin receptors in the brain, helping to regulate the sleep-wake cycle. Studies have demonstrated its safety and efficacy, making it a well-tolerated option for improving sleep parameters in patients with chronic insomnia.

What other types of research exist?

One promising alternative to melatonin for its antioxidant properties is acetyl-melatonin (AMLT) and benzoyl-melatonin (BMLT), which have shown significant antioxidant activity in human gingival fibroblasts. For chronobiotic effects, light therapy, particularly using broad-spectrum white light boxes, is a viable option. This therapy involves morning light exposure to shift circadian rhythms earlier, which can be effective in motivated patients when combined with behavioral education.

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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

Drug Has Already Been Approved

Pivotal Trial

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 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

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

Nausea

Dyspnea

Diarrhea

Postoperative Pain

Constipation

Cough

Vomiting

Peripheral Neuropathy

Headache

Neutropenia

Appetite changes

Air Leak

Dizziness

Chest pain

Cold/Flu Symptoms

Flatulence

GERD

Back pain

New Neoplasm

Weight loss

Acid reflux

Gall bladder attack

Anemia

Pulmonary embolism

Vertigo

Pneumonia

Bonchitis

Pneumothorax

Syncope

New Neoplasm - Lung Cancer

Tinnitus

Anorexia

Anxiety

Depression

Subcutaneous Emphysema

dry mouth

Erythema

Epistaxis

Pruritis

Rash

Prolonged Air Leak

Hyperglycemia

Thrush (mouth)

Hip replacement surgery

Atrial fibrillation

Indigestion

Peripheral Edema

C-Difficile

Surgical site infection

Fall

Pain

Radiation pneumonitis

Surgical Site Pain

Dry Cough

Pleural effusion

Hypertension

Tachycardia

Dysphagia

Sinus infection

Myalgia

Hearing loss

Hemoptysis

100%

80%

60%

40%

20%

Study treatment Arm

Melatonin

Placebo

Awards & Highlights

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.

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

0 / 3Eligibility criteria met

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.