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

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT06826755
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
40 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
May 23, 2025
Status verified
Jul 2025
Primary completion
Sep 30, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Placebo Comparator: 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.
  • Other: 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.

Primary Outcome Measure

Change in Nocturnal Systolic Blood Pressure (SBP) [ Time Frame: Measured at baseline and at the end of the 12-week intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905
Naima Covassin, Ph.D.
[email protected]
Naima Covassin, Ph.D. (PRINCIPAL_INVESTIGATOR)

Find similar trials in Rochester, MN

By condition
Hypertension (high blood pressure)Menopause
By specialty
CardiologyHeart diseaseWomen's healthFertility
By research site
Mayo Clinic in Rochester· Rochester, MN

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