Melatonin for High Blood Pressure

Overseen By Perimenopause Study Team

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Mayo Clinic

Must be taking: Antihypertensives

Must not be taking: Sleeping medications, Melatonin, Aspirin

Disqualifiers: Pregnancy, Night shift work, Cancer, others

Compensation: Varies

Number of Visits: 12

Duration: 12 weeks

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how melatonin may help manage high blood pressure in women undergoing menopause. Researchers aim to determine if taking melatonin for 12 weeks improves blood pressure compared to a placebo (a pill with no active ingredient). The trial targets women aged 40-55 who have begun experiencing menopause symptoms, such as irregular periods, and have been diagnosed with high blood pressure. Participants must not currently use sleep medications or melatonin. As an unphased trial, this study provides an opportunity to contribute to understanding how melatonin might benefit women with high blood pressure during menopause.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must be on a stable medical regimen for at least 2 months if you are taking other medications.

Is there any evidence suggesting that melatonin is likely to be safe for humans?

Research has shown that melatonin is generally safe to use. For example, studies have found that taking melatonin regularly can lower blood pressure during sleep without affecting heart rate, indicating it is well-tolerated for short-term use.

However, some studies suggest that melatonin might raise blood pressure in individuals already on blood pressure medication, so discussing this with a doctor is important. Another study found that melatonin does not negatively affect arterial flexibility, supporting its safety.

In summary, melatonin appears safe for most people, especially for short-term use, but those on blood pressure medication should exercise caution. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for high blood pressure, which often include medications like ACE inhibitors, beta-blockers, and diuretics, melatonin is a naturally occurring hormone that regulates sleep. Researchers are excited about melatonin because it has the potential to lower blood pressure by improving sleep quality and reducing nighttime blood pressure levels. This treatment could offer a gentler approach with fewer side effects compared to traditional medications. Plus, since melatonin is a widely used supplement for sleep disorders, it may be more accessible and affordable for patients.

What evidence suggests that melatonin might be an effective treatment for high blood pressure?

Research has shown that melatonin can help lower blood pressure. In some studies, taking melatonin at night reduced the systolic blood pressure (when the heart beats) by 6 mm Hg and the diastolic pressure (when the heart rests) by 4 mm Hg during sleep, without affecting heart rate. Another study found that melatonin also helped lower diastolic blood pressure during the day in adults. Additionally, melatonin has lowered blood pressure in both humans and animals. In this trial, participants will receive either melatonin or a placebo to observe its effects on cardiovascular risk measures in perimenopausal women. These findings suggest that melatonin could be a useful treatment for high blood pressure, especially at night. ^{2 4 6 7 8}

Who Is on the Research Team?

Naima Covassin, Ph.D.

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for women aged 40-55 who are in the menopause transition, with high blood pressure. They must have an intact uterus and at least one ovary, fit the STRAW bleeding pattern criteria for perimenopause, and be on a stable medication regimen if taking other drugs.

Inclusion Criteria

My current medications have not changed in the last 2 months.

I am a woman with at least one ovary and a uterus.

I am between 40 and 55 years old.

Exclusion Criteria

Severe lactose intolerance

History of substance use disorder

Current or recent (within the past 2 months) participation in other research studies at the discretion of study investigators

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive melatonin or placebo supplementation for 12 weeks

12 weeks

Measured at baseline and at the end of the 12-week intervention

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Melatonin

Trial Overview

The study tests whether melatonin supplements can affect cardiovascular disease mechanisms over 12 weeks compared to a placebo in perimenopausal women with high blood pressure.

How Is the Trial Designed?

Group I: Melatonin Experimental Treatment 1 Intervention

Melatonin will be taken orally once daily, one hour before bedtime. The use of melatonin is not experimental but rather to observe its effects vs. placebo on cardiovascular risk measures in perimenopausal women.

Group II: Placebo Placebo Group 1 Intervention

placebo will be taken orally once daily, one hour before bedtime. Placebo will be prepared as capsules of identical appearance and taste, using lactose powder as filler.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

Timed melatonin administration may offer a new treatment approach for cardiac ischemia and hypertension that does not respond to traditional medications, suggesting its potential efficacy in managing these conditions.

The study builds on previous research linking melatonin to blood pressure regulation and circadian rhythms, indicating that timing of melatonin could be crucial for optimizing its therapeutic effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Melatonin, refractory hypertension, myocardial ischemia and other challenges in nightly blood pressure lowering. Zaslavskaya, RM., Lilitsa, GV., Dilmagambetova, GS., et al.[2019]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10848819/

The Effect of Melatonin Supplement on High Arterial Blood ...

Melatonin has been shown to be an effective treatment for lowering blood pressure. More research is required to fully establish the potential benefits and ...

2.

ahajournals.org

ahajournals.org/doi/10.1161/01.hyp.0000113293.15186.3b

Daily Nighttime Melatonin Reduces Blood Pressure in ...

Repeated melatonin intake reduced systolic and diastolic blood pressure during sleep by 6 and 4 mm Hg, respectively. The treatment did not affect heart rate.

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S2405844024106354

Effect of melatonin supplementation on body composition ...

The current meta-analysis of RCTs shows that treatment with melatonin reduces HC and daytime DBP levels in adults.

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC2014953/

Cardiovascular effects of melatonin in hypertensive ...

Melatonin administration has been shown to induce a hypotensive effect in both normotensive [14, 15] and spontaneously hypertensive rats [13, 16]. A lowering of ...

5.

journals.physiology.org

journals.physiology.org/doi/abs/10.1152/ajpregu.00101.2023

Melatonin supplementation reduces nighttime blood ...

Melatonin supplementation reduces nighttime blood pressure but does not affect blood pressure reactivity in normotensive adults on a high-sodium diet.

6.

newsroom.heart.org

newsroom.heart.org/news/long-term-use-of-melatonin-supplements-to-support-sleep-may-have-negative-health-effects

Long-term use of melatonin supplements to support sleep ...

The association between melatonin and increased risk of heart failure or death found in this study, which cannot prove a cause-and-effect ...

7.

mayoclinic.org

mayoclinic.org/drugs-supplements-melatonin/art-20363071

Melatonin

Blood pressure drugs. Melatonin might worsen blood pressure in people taking blood pressure medications.

8.

sciencedirect.com

sciencedirect.com/science/article/pii/S0965229924000141

Effects of melatonin on blood pressure, arterial stiffness ...

We do, however, conclude that melatonin in high doses are safe to use when given in relation to other matters. We saw no detectable changes in arterial ...