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Antioxidant

Melatonin for Cardiovascular Risk

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
healthy
normal blood pressure
Must not have
Be younger than 18 years old
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upday 10
Awards & highlights

Study Summary

This trial will see if melatonin can help reduce the negative effects of increased dietary sodium on blood vessels.

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 10
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 10 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Conduit artery endothelial-dependent function
Microvascular function
Secondary outcome measures
Blood pressure reactivity

Side effects data

From 2014 Phase 2 trial • 40 Patients • NCT01114373
42%
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
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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Melatonin and Salt on Blood Vessel Function
2020. "Melatonin and Salt on Blood Vessel Function". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04325191.
All > Melatonin
~3 spots leftby Nov 2024
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