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

Trial Summary

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.

What evidence supports the effectiveness of the drug melatonin for high blood pressure?

Research shows that melatonin can help lower blood pressure, especially at night, in people with high blood pressure. It works by improving blood flow and relaxing blood vessels, and has been shown to reduce blood pressure in both animal studies and human trials. ^{1 2 3 4 5}

Is melatonin safe for humans?

Melatonin has been studied in various trials and is generally considered safe for humans, with some studies showing it can help lower blood pressure, especially at night. However, more research is needed to fully understand its long-term safety and effects. ^{1 4 5 6 7}

How does the drug melatonin differ from other treatments for high blood pressure?

Melatonin is unique because it not only helps regulate blood pressure by improving the function of blood vessels and reducing stress hormones, but it also works as an antioxidant. Unlike many standard blood pressure medications, melatonin is a natural hormone that can be particularly effective for people whose blood pressure does not drop at night as it should. ^{2 4 7 8 9}

What is the purpose of this trial?

The purpose of this research is to study the effects of 12 weeks of melatonin supplementation compared to placebo in women who are in the menopause transition (perimenopause) and have high blood pressure.

Research Team

Naima Covassin, Ph.D.

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[THE INFLUENCE OF MELATONIN ON THE PARAMETERS OF CEREBRAL HEMODYNAMICS IN PATIENTS WITH HYPERTENSIVE DISEASE]. [2016]

2. England pubmed.ncbi.nlm.nih.gov

Melatonin as a potential antihypertensive treatment. [2013]

3. France pubmed.ncbi.nlm.nih.gov

Melatonin, refractory hypertension, myocardial ischemia and other challenges in nightly blood pressure lowering. [2019]

4. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Melatonin and hypertension: a possible role in combination therapy]. [2018]

5. England pubmed.ncbi.nlm.nih.gov

The effects of melatonin supplementation on blood pressure in patients with metabolic disorders: a systematic review and meta-analysis of randomized controlled trials. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Melatonin reduces night blood pressure in patients with nocturnal hypertension. [2013]

7. United States pubmed.ncbi.nlm.nih.gov

Antihypertensive action of melatonin in the spontaneously hypertensive rat. [2022]

8. Sweden pubmed.ncbi.nlm.nih.gov

Melatonin and the cardiovascular system. [2013]

9. England pubmed.ncbi.nlm.nih.gov

Effect of bedtime melatonin ingestion on blood pressure of normotensive subjects. [2019]