NCT06826755NARecruiting
Melatonin Effects on Cardiovascular Disease Mechanisms in Midlife Women: A Randomized Clinical Trial
Mayo Clinic
Start Date
5/23/2025
Completion Date
1/1/2027
Summary
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
Age Range: 40 years to 55 years
Inclusion Criteria
* Age 40-55 years old
* Female individuals with intact uterus and at least one ovary
* Hypertension
o Defined as a prior diagnosis of hypertension, use of antihypertensive agents, or office SBP/DBP ≥130/80 mmHg
* On stable medical regimen (≥ 2 months) if taking other medications
Exclusion Criteria
* Prescription sleeping medications or melatonin supplementation
* Pregnant or lactating
* Use of tobacco, nicotine or vaping products
* Night shift work
* On prescription aspirin
* Severe lactose intolerance
* History of substance use disorder
* History of suicidal ideation
* History of clinically diagnosed anemia (within the past 5 years) or low hemoglobin levels (\<11.6 g/dL) within the past 12 months
* Active cancer
* Severe daytime sleepiness (score \>15 at the Epworth Sleepiness Scale \[ESS\])81
* Current or recent (within the past 2 months) participation in other research studies at the discretion of study investigators
* Inability to provide written consent and/or to speak and read English
* Any other medical, geographic, or social factor making study participation impractical
Interventions
DIETARY_SUPPLEMENT
Terry Naturally® melatonin 5mg SR
DIETARY_SUPPLEMENT
Placebo
Conditions
PerimenopauseHypertension
Locations
Mayo Clinic in Rochester
Rochester, Minnesota 55905
United States