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Dietary Sodium Restriction for Salt Sensitivity
Phase 4
Recruiting
Led By David G Edwards, 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 change from baseline at 4 weeks
Awards & highlights
Study Summary
This trial will study how reducing dietary salt affects blood pressure and vascular function in people who are sensitive to salt.
Who is the study for?
This trial is for men and women who typically eat more than 3400mg of sodium daily and have normal blood pressure that doesn't change much with salt intake. They must be able to consent, have a normal ECG, blood tests, not be on blood pressure meds or pregnant, not obese, and free from heart disease, cancer, diabetes or kidney issues.Check my eligibility
What is being tested?
The study aims to see how eating less salt affects the body's central hemodynamics (how the heart pumps blood) and vascular function (how the blood vessels work). Participants will follow a low-sodium diet compared to their usual high intake.See study design
What are the potential side effects?
Since this trial involves dietary changes rather than medication, side effects are minimal but may include temporary discomforts like cravings or feeling unsatisfied with less salty foods.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline at 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline at 4 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Reflected Pulse Wave Amplitude
Secondary outcome measures
Arterial Stiffness
Conduit Artery Endothelial Dependent Dilation
Forward pulse wave amplitude
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Dietary Sodium RestrictionExperimental Treatment1 Intervention
Daily habitual dietary sodium intake < 2000mg
Group II: ControlPlacebo Group1 Intervention
Routine habitual dietary sodium intake >3400mg
Find a Location
Who is running the clinical trial?
University of DelawareLead Sponsor
154 Previous Clinical Trials
25,086 Total Patients Enrolled
David G Edwards, PhDPrincipal InvestigatorUniversity of Delaware
3 Previous Clinical Trials
94 Total Patients Enrolled
William B Farquhar, PhDPrincipal InvestigatorUniversity of Delaware
4 Previous Clinical Trials
166 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am unable to give my consent.You regularly consume more than 3400mg of sodium per day in your diet.I have high blood pressure or am on medication for it.You have a body mass index (BMI) higher than 30, which means you are considered obese.I have a history of heart disease, cancer, diabetes, or kidney problems.
Research Study Groups:
This trial has the following groups:- Group 1: Dietary Sodium Restriction
- Group 2: Control
Awards:
This trial has 2 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there an upper age limit for enrollment in this trial?
"All participants in this medical trial must be of age and below 45 years."
Answered by AI
Has the FDA sanctioned Dietary Sodium Restriction as a viable therapy?
"The safety of dietary sodium restriction has been confirmed in Phase 4 trials, thus it scored a 3 on our scale."
Answered by AI
Who are the eligibile participants in this medical investigation?
"To be admitted to this clinical trial, individuals must have healthy subjects (HS) and be in the age-range of 21 to 45. A total of 125 people may join."
Answered by AI
How many individuals are eligible to take part in this experiment?
"Affirmative. As per the details published on clinicaltrials.gov, this medical trial which first launched in January of 2018 is actively recruiting participants and requires 125 individuals from a single centre to take part. The listing was last updated on June 9th 2022."
Answered by AI
Are there any remaining openings in this clinical experiment for participants?
"Affirmative, the information available through clinicaltrials.gov indicates that this research project is currently in need of participants. The trial was first made public on January 21st 2018 and most recently revised on June 9th 2022. 125 volunteers are to be recruited from a single medical site."
Answered by AI
Who else is applying?
What state do they live in?
Maryland
What site did they apply to?
Department of Kinesiology and Applied Physiology, University of Delaware
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How responsive is this trial?
Typically responds via
Phone Call
Most responsive sites:
- Department of Kinesiology and Applied Physiology, University of Delaware: < 48 hours
Average response time
- < 2 Days
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