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Antioxidant
Melatonin and Salt on Blood Vessel Function
N/A
Waitlist Available
Led By Shannon L Lennon, PhD
Research Sponsored by University of Delaware
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 10
Summary
This trial will see if melatonin can help reduce the negative effects of increased dietary sodium on blood vessels.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 10
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 10
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Conduit artery endothelial-dependent function
Microvascular function
Secondary study objectives
Blood pressure reactivity
Side effects data
From 2014 Phase 2 trial • 40 Patients • NCT0111437342%
Fatigue
39%
Early Morning Wakening
36%
Daytime drowsiness
11%
Weakness
11%
Dizziness
11%
Nausea
11%
Blurred vision
100%
80%
60%
40%
20%
0%
Study treatment Arm
Melatonin
Placebo
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Melatonin
2014
Completed Phase 4
~1150
Find a Location
Who is running the clinical trial?
University of DelawareLead Sponsor
161 Previous Clinical Trials
25,577 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