Melatonin Effects on Cardiovascular Disease Mechanisms in Midlife Women: A Randomized Clinical Trial
NCT ID: NCT06826755
Last Updated: 2025-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
70 participants
INTERVENTIONAL
2025-05-23
2027-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
TRIPLE
Study Groups
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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.
Placebo
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.
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.
Terry Naturally® melatonin 5mg SR
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.
Interventions
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Terry Naturally® melatonin 5mg SR
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
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
55 Years
FEMALE
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Naima Covassin
Principal Investigator
Principal Investigators
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Naima Covassin, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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24-008966
Identifier Type: -
Identifier Source: org_study_id
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