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Melatonin for Cardiovascular Risk
Led By Shannon L Lennon, PhD
Research Sponsored by University of Delaware
Eligibility Criteria ChecklistSpecific guidelines that determine who can or cannot participate in a clinical trial
normal blood pressure
Must not have
Be younger than 18 years old
Be older than 65 years old
Screening 3 weeks
Follow Upday 10
Awards & highlights
This trial will see if melatonin can help reduce the negative effects of increased dietary sodium on blood vessels.
Inclusion CriteriaYou will be eligible if you check “Yes” for the criteria below
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 10
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 10 for reporting.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 10
Study ObjectivesOutcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Conduit artery endothelial-dependent function
Secondary outcome measures
Blood pressure reactivity
Side effects dataFrom 2014 Phase 2 trial • 40 Patients • NCT01114373
Early Morning Wakening
Study treatment Arm
Group I: High Salt and MelatoninExperimental Treatment1 Intervention
Subjects will consume sodium pills throughout the day achieving a total of 6900 mg sodium/day (4600 mg of sodium from pills and 2300 mg from diet) and will supplement with 10 mg (single dose) of melatonin at night.
Group II: High Salt and PlaceboPlacebo Group1 Intervention
Subjects will consume sodium pills throughout the day achieving a total of 6900 mg sodium/day (4600 mg of sodium from pills and 2300 mg from diet) and will supplement with a lactose placebo (single dose) at night.
Drug Approval Stage
How many patients have taken this drug
Completed Phase 4
Find a Location
Who is running the clinical trial?
University of DelawareLead Sponsor
147 Previous Clinical Trials
24,434 Total Patients Enrolled
7 Trials studying Cardiovascular Risk
383 Patients Enrolled for Cardiovascular Risk
Shannon L Lennon, PhDPrincipal InvestigatorUniversity of Delaware
2 Previous Clinical Trials
137 Total Patients Enrolled
2 Trials studying Cardiovascular Risk
137 Patients Enrolled for Cardiovascular Risk
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