Melatonin Effects on Cardiovascular Disease Mechanisms in Midlife Women: A Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Mayo Clinic
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Change in Nocturnal Systolic Blood Pressure (SBP)
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 55 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Placebo
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.
Intervention: Placebo (Dietary Supplement)
Melatonin
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.
Intervention: Terry Naturally® melatonin 5mg SR (Dietary Supplement)
Outcomes
Primary Outcomes
Change in Nocturnal Systolic Blood Pressure (SBP)
Time Frame: Measured at baseline and at the end of the 12-week intervention
Measured using 24-hour ambulatory blood pressure (ABP) monitoring, including nighttime BP levels and nocturnal BP dipping.
Change in Nocturnal Diastolic Blood Pressure (DBP)
Time Frame: Measured at baseline and at the end of the 12-week intervention.
Measured using 24-hour ambulatory blood pressure (ABP) monitoring, including nighttime BP levels and nocturnal BP dipping.
Secondary Outcomes
- Change in Oxidative Stress Markers(Measured at baseline and at the end of the 12-week intervention.)
Investigators
Naima Covassin
Principal Investigator
Mayo Clinic