Health TrialsbyHealthPanel

Melatonin Effects on Cardiovascular Disease Mechanisms in Midlife Women: A Randomized Clinical Trial

ConditionsPerimenopauseHypertension
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40-55
SponsorMayo Clinic

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 40-55 years old

Female individuals with intact uterus and at least one ovary

Hypertension

On stable medical regimen (≥ 2 months) if taking other medications

Disqualifiers

Prescription sleeping medications or melatonin supplementation

Pregnant or lactating

Use of tobacco, nicotine or vaping products

Night shift work

Trial design

Design model

Parallel

Treatments tested in this trial

  • Terry Naturally® melatonin 5mg SR

    Dietary supplement

    Participants will take SR melatonin 5mg (or placebo) orally 1 hour before bed, for approximately 12 weeks. The study is comparing the effects of melatonin supplementation vs. placebo on cardiovascular risk measures in perimenopausal women.

  • Placebo

    Dietary supplement

    Participants will take SR melatonin 5mg (or placebo) orally 1 hour before bed, for approximately 12 weeks. The study is comparing the effects of melatonin supplementation vs. placebo on cardiovascular risk measures in perimenopausal women.

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: PlaceboPlacebo comparator 1 intervention
Group B: MelatoninOther 1 intervention

Trial outcomes

Primary outcomes

1

Change in Nocturnal Systolic Blood Pressure (SBP)

Measured using 24-hour ambulatory blood pressure (ABP) monitoring, including nighttime BP levels and nocturnal BP dipping.

Time frame
Measured at baseline and at the end of the 12-week intervention
2

Change in Nocturnal Diastolic Blood Pressure (DBP)

Measured using 24-hour ambulatory blood pressure (ABP) monitoring, including nighttime BP levels and nocturnal BP dipping.

Time frame
Measured at baseline and at the end of the 12-week intervention.

Secondary outcomes

1

Change in Oxidative Stress Markers

Assessed using Blood and urine samples analyzed by Mayo Clinic Laboratories.

Time frame
Measured at baseline and at the end of the 12-week intervention.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov
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