Uric Acid, Klotho and Salt Sensitivity in Young Adults Born Preterm (PEPC3)

March 26, 2026 updated by: Wake Forest University Health Sciences
The purpose of this research is to learn about how salt in the diet influences blood pressure in young adults who were born prematurely.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Premature birth is an emerging and important risk factor for hypertension and cardiovascular disease, as both preterm birth rates and infant survival increase worldwide. Hypertension and cardiovascular disease begin in early adulthood in individuals born prematurely, but the reasons especially in regard to the role of preterm birth are unknown. An improved understanding of why hypertension and cardiovascular disease occur in early adulthood in individuals born preterm will enable the development of prevention and treatment strategies to mitigate the burden of cardiovascular disease. Investigators propose to investigate these relationships mechanistically in a clinical trial of subjects born preterm to establish the SSBP (salt sensitivity of blood pressure) phenotype and study its relationship to CVD (cardiovascular disease) compared to a control group of healthy term- born peers. Investigators will then propose to determine if blocking UA (uric acid) formation improves SSBP and cardiovascular function in subjects born preterm.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Wake Forest University Health Sciences
        • Contact:
        • Principal Investigator:
          • Hossam Shaltout, PhD
        • Sub-Investigator:
          • Andrew South, MD, MS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

24 years to 32 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Singleton birth
  • Born at less than 34 weeks gestational age (preterm cohort)
  • Born at greater than 36 weeks gestational age (term cohort)

Exclusion Criteria:

  • Twin birth
  • Congenital anomalies or genetic syndromes
  • Currently pregnant or breast feeding
  • Subject-reported history of hypertension
  • Current use of antihypertensive medications
  • Active cancer
  • Chronic kidney disease
  • Heart failure
  • Liver failure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Preterm Group
Subjects with very low birth weight (<37 completed weeks' gestation and birth weight <1500 g) will receive a dietary intervention (high/low salt diet) and FDA approved drug, Allopurinol
Drug: Allopurinol
Study Part 2- Preterm group only: After Visit 5 preterm born participants will start allopurinol 200 mg daily PO for 6 weeks. The 1 week high and low salt diets and assessments will be repeated while on allopurinol.
Other Names:
  • Zyloprim
Other: Dietary Intervention
High-Na+ (250 mmol/d) and low-Na+ (50 mmol/d) standard isocaloric K+ diets (75 mmol/1000 kcal/d) for 1 week each as 3 meals and 1 snack a day provided by the Clinical Research Unit Metabolic Kitchen. Part 2 preterm only- the diets will be repeated while the participant is taking allopurinol.
Active Comparator: Term-born control group
Subjects with birth weight ≥2500 g will receive a dietary intervention (high/low salt diet)
Other: Dietary Intervention
High-Na+ (250 mmol/d) and low-Na+ (50 mmol/d) standard isocaloric K+ diets (75 mmol/1000 kcal/d) for 1 week each as 3 meals and 1 snack a day provided by the Clinical Research Unit Metabolic Kitchen. Part 2 preterm only- the diets will be repeated while the participant is taking allopurinol.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion with salt sensitivity of blood pressure at baseline via ABPM
Time Frame: Day 7 to 14
Defined as a ≥8 mmHg decrease in mean arterial blood pressure when moving from the high-Na+ to the low-Na+ phase, as measured on 24-hour ambulatory blood pressure monitoring (ABPM).
Day 7 to 14
Proportion with salt sensitivity of blood pressure after allopurinol via ABPM
Time Frame: Day 49 to 56
A ≥8 mmHg decrease in mean arterial blood pressure when moving from the high-Na+ to the low-Na+ phase while taking allopurinol, as measured on 24-hour ambulatory blood pressure monitoring (ABPM).
Day 49 to 56
Salt sensitivity index at baseline
Time Frame: Day 7 to 14
The ratio between the change in 24-hour mean arterial pressure, as measured on 24-hour ambulatory blood pressure monitoring, and the change in 24-hour urine Na+ concentration when moving from the high-Na+ phase to the low-Na+ phase.
Day 7 to 14
Salt sensitivity index after allopurinol
Time Frame: Day 49 to 56
The ratio between the change in 24-hour mean arterial pressure, as measured on 24-hour ambulatory blood pressure monitoring, and the change in 24-hour urine Na+ concentration when moving from the high-Na+ phase to the low-Na+ phase while taking allopurinol
Day 49 to 56
Proportion with salt sensitivity of blood pressure at baseline via casual blood pressure
Time Frame: Day 7 to 14
A >=5 mmHg decrease in mean arterial blood pressure measured in clinic when moving from the high-Na+ phase to the low-Na+ phase. Casual blood pressure measured 3 consecutive times via auscultation with the average of the 3 mean arterial blood pressure measurements recorded.
Day 7 to 14
Proportion with salt sensitivity of blood pressure after allopurinol via casual blood pressure
Time Frame: Day 49 to 56
A >=5 mmHg decrease in mean arterial blood pressure measured in clinic when moving from the high-Na+ phase to the low-Na+ phase while taking allopurinol. Casual blood pressure measured 3 consecutive times via auscultation with the average of the 3 mean arterial blood pressure measurements recorded.
Day 49 to 56
High blood pressure at baseline via ABPM
Time Frame: Day 0
Proportion with 24-hour mean systolic or diastolic blood pressure ≥115/75 mmHg, awake mean systolic or diastolic blood pressure ≥120/80 mmHg, or asleep mean systolic or diastolic blood pressure ≥100/65 mmHg, measured with ambulatory blood pressure monitoring (ABPM).
Day 0
Hypertension at baseline via ABPM
Time Frame: Day 7
Proportion with 24-hour mean systolic or diastolic blood pressure ≥125/75 mmHg, awake mean systolic or diastolic blood pressure ≥130/80 mmHg, or asleep mean systolic or diastolic blood pressure ≥110/65 mmHg, measured with ambulatory blood pressure monitoring (ABPM).
Day 7
High blood pressure at baseline via casual blood pressure
Time Frame: First 3 study visits
Proportion with mean systolic or diastolic blood pressure ≥120/80 mmHg, measured via 3 consecutive auscultated measurements (averaged) at each of 3 separate study visits.
First 3 study visits
Hypertension at baseline via casual blood pressure
Time Frame: First 3 study visits
Proportion with mean systolic or diastolic blood pressure ≥130/80 mmHg, measured via 3 consecutive auscultated measurements (averaged) at each of 3 separate study visits
First 3 study visits
Serum uric acid at baseline
Time Frame: Day 0
Serum uric acid concentration at baseline
Day 0
Change in serum uric acid with dietary Na+ intervention
Time Frame: Day 7 to 14
The change in serum uric acid levels when moving from high-Na+ phase to the low-Na+ phase
Day 7 to 14
Change in serum uric acid with dietary Na+ intervention on allopurinol
Time Frame: Day 42 to 56
The change in serum uric acid levels when moving from high-Na+ phase to the low-Na+ phase while on allopurinol
Day 42 to 56
Pulse wave velocity at baseline
Time Frame: Day 0
Carotid femoral pulse wave velocity will be measured at baseline with the SphygmoCor XCEL device
Day 0
Augmentation index at baseline
Time Frame: Day 0
Augmentation index will be measured at baseline with the SphygmoCor XCEL device
Day 0
Heart rate variability at baseline
Time Frame: Day 0
Heart rate variability will be measured at baseline using continuous heart rate recording using the CNAP™ Monitor 500i
Day 0
Baroreflex sensitivity at baseline
Time Frame: Day 0
Baroreflex sensitivity will be measured at baseline using continuous blood pressure and heart rate using the CNAP™ Monitor 500i
Day 0
Angiotensin-(1-7) at baseline
Time Frame: Day 0
Plasma angiotensin-(1-7) concentration and urine angiotensin-(1-7)/creatinine at baseline
Day 0
Angiotensin II at baseline
Time Frame: Day 0
Plasma angiotensin II concentration and urine angiotensin II/creatinine at baseline
Day 0
Klotho at baseline
Time Frame: Day 0
Plasma klotho concentration and urine klotho/creatinine at baseline.
Day 0
Creatinine at baseline
Time Frame: Day 0
Serum creatinine concentration at baseline
Day 0
Cystatin C at baseline
Time Frame: Day 0
Serum cystatin C concentration at baseline
Day 0
eGFR at baseline
Time Frame: Day 0
Estimated glomerular filtration rate (eGFR) at baseline.We will calculate the eGFR by the CKD-EPI Creatinine-Cystatin C 2012 equation and by 24 hour creatinine
Day 0

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Ambulatory systolic blood pressure 24-hour mean at baseline
Time Frame: Day 0
Average systolic blood pressure over 24 hours, measured with ambulatory blood pressure monitors
Day 0
Ambulatory diastolic blood pressure 24-hour mean at baseline
Time Frame: Day 0
Average diastolic blood pressure over 24 hours, measured with ambulatory blood pressure monitors
Day 0
Ambulatory mean arterial pressure 24-hour mean at baseline
Time Frame: Day 0
Average mean arterial pressure over 24 hours, measured with ambulatory blood pressure monitors
Day 0
Ambulatory systolic blood pressure awake mean at baseline
Time Frame: Day 0
Average systolic blood pressure while awake, measured with ambulatory blood pressure monitors
Day 0
Ambulatory diastolic blood pressure awake mean at baseline
Time Frame: Day 0
Average diastolic blood pressure while awake, measured with ambulatory blood pressure monitors
Day 0
Ambulatory mean arterial pressure awake mean at baseline
Time Frame: Day 0
Average mean arterial pressure while awake, measured with ambulatory blood pressure monitors
Day 0
Ambulatory systolic blood pressure asleep mean at baseline
Time Frame: Day 0
Average systolic blood pressure while asleep, measured with ambulatory blood pressure monitors
Day 0
Ambulatory diastolic blood pressure asleep mean at baseline
Time Frame: Day 0
Average diastolic blood pressure while asleep, measured with ambulatory blood pressure monitors
Day 0
Ambulatory mean arterial pressure asleep mean at baseline
Time Frame: Day 0
Average mean arterial pressure while asleep, measured with ambulatory blood pressure monitors
Day 0
Ambulatory systolic blood pressure 24-hour load at baseline
Time Frame: Day 0
Proportion of mean 24-hour systolic blood pressures ≥125 mmHg, measured with ambulatory blood pressure monitors
Day 0
Ambulatory diastolic blood pressure 24-hour load at baseline
Time Frame: Day 0
Proportion of mean 24-hour diastolic blood pressures ≥75 mmHg, measured with ambulatory blood pressure monitors.
Day 0
Ambulatory systolic blood pressure awake load at baseline
Time Frame: Day 0
Proportion of mean awake systolic blood pressures ≥130 mmHg, measured with ambulatory blood pressure monitors
Day 0
Ambulatory diastolic blood pressure awake load at baseline
Time Frame: Day 0
Proportion of mean awake diastolic blood pressures ≥80 mmHg, measured with ambulatory blood pressure monitors
Day 0
Ambulatory systolic blood pressure asleep load at baseline
Time Frame: Day 0
Proportion of mean asleep systolic blood pressures ≥110 mmHg, measured with ambulatory blood pressure monitors
Day 0
Ambulatory diastolic blood pressure asleep load at baseline
Time Frame: Day 0
Proportion of mean asleep diastolic blood pressures ≥65 mmHg, measured with ambulatory blood pressure monitors
Day 0
Ambulatory systolic blood pressure nocturnal dipping at baseline
Time Frame: Day 0
Percent change in mean awake to mean asleep systolic blood pressure, measured with ambulatory blood pressure monitors
Day 0
Ambulatory diastolic blood pressure nocturnal dipping at baseline
Time Frame: Day 0
Percent change in mean awake to mean asleep diastolic blood pressure, measured with ambulatory blood pressure monitors
Day 0
Casual systolic blood pressure at baseline
Time Frame: Day 0
Measured 3 consecutive times via auscultation with the average of the 3 systolic blood pressure measurements recorded
Day 0
Casual diastolic blood pressure at baseline
Time Frame: Day 0
Measured 3 consecutive times via auscultation with the average of the 3 diastolic blood pressure measurements recorded
Day 0
Change in pulse wave velocity with dietary Na+ intervention
Time Frame: Day 7 to 14
The change in carotid femoral pulse wave velocity will be measured with the SphygmoCor XCEL device when moving from high-Na+ phase to the low-Na+ phase
Day 7 to 14
Change in augmentation index with dietary Na+ intervention
Time Frame: Day 7 to 14
The change in augmentation index will be measured with the SphygmoCor XCEL device when moving from high-Na+ phase to the low-Na+ phase
Day 7 to 14
Change in pulse wave velocity with dietary Na+ intervention while on allopurinol
Time Frame: Day 49 to 56
The change in carotid femoral pulse wave velocity will be measured with the SphygmoCor XCEL device when moving from high-Na+ phase to the low-Na+ phase while on allopurinol.
Day 49 to 56
Change in augmentation index with dietary Na+ intervention while on allopurinol
Time Frame: Day 49 to 56
The change in augmentation index will be measured with the SphygmoCor XCEL device when moving from high-Na+ phase to the low-Na+ phase while on allopurinol
Day 49 to 56
Change in heart rate variability with dietary Na+ intervention
Time Frame: Day 7 to 14
The change in heart rate variability will be measured using the Continuous noninvasive arterial pressure (CNAP™) Monitor 500i when moving from high-Na+ phase to the low-Na+ phase
Day 7 to 14
Change in baroreflex sensitivity with dietary Na+ intervention
Time Frame: Day 7 to 14
The change in baroreflex sensitivity will be measured using the CNAP™ Monitor 500i when moving from high-Na+ phase to the low-Na+ phase
Day 7 to 14
Change in heart rate variability with dietary Na+ intervention while on allopurinol
Time Frame: Day 49 to 56
The change in heart rate variability will be measured using the CNAP™ Monitor 500i when moving from high-Na+ phase to the low-Na+ phase while on allopurinol
Day 49 to 56
Change in baroreflex sensitivity with dietary Na+ intervention while on allopurinol
Time Frame: Day 49 to 56
The change in baroreflex sensitivity will be measured using the CNAP™ Monitor 500i when moving from high-Na+ phase to the low-Na+ phase while on allopurinol
Day 49 to 56
Change in angiotensin-(1-7) with dietary Na+ intervention
Time Frame: Day 7 to 14
The change in plasma angiotensin-(1-7) concentration and urine angiotensin-(1-7)/creatinine when moving from the high-Na+ phase to the low-Na+ phase
Day 7 to 14
Change in angiotensin II with dietary Na+ intervention
Time Frame: Day 7 to 14
The change in plasma angiotensin II concentration and urine angiotensin II/creatinine when moving from the high-Na+ phase to the low-Na+ phase
Day 7 to 14
Change in klotho with dietary Na+ intervention
Time Frame: Day 7 to 14
The change in plasma klotho concentration and urine klotho/creatinine when moving from the high-Na+ phase to the low-Na+ phase
Day 7 to 14
Change in angiotensin-(1-7) with dietary Na+ intervention while on allopurinol
Time Frame: Day 49 to 56
The change in plasma angiotensin-(1-7) concentration and urine angiotensin-(1-7)/creatinine when moving from the high-Na+ phase to the low-Na+ phase while on allopurinol
Day 49 to 56
Change in angiotensin II with dietary Na+ intervention while on allopurinol
Time Frame: Day 49 to 56
The change in plasma angiotensin II concentration and urine angiotensin II/creatinine when moving from the high-Na+ phase to the low-Na+ phase while on allopurinol
Day 49 to 56
Change in klotho with dietary Na+ intervention while on allopurinol
Time Frame: Day 49 to 56
The change in plasma klotho concentration and urine klotho/creatinine when moving from the high-Na+ phase to the low-Na+ phase while on allopurinol
Day 49 to 56
ACE2 at baseline
Time Frame: Day 0
Serum ACE2 concentration and activity and urine ACE2/creatinine and activity at baseline
Day 0
ACE at baseline
Time Frame: Day 0
Serum ACE concentration and activity and urine ACE/creatinine and activity at baseline
Day 0
FGF23 at baseline
Time Frame: Day 0
Plasma fibroblast growth factor 23 (FGF23) concentration and urine FGF23/creatinine at baseline
Day 0
Change in ACE2 with dietary Na+ intervention
Time Frame: Day 7 to 14
The change in serum ACE2 concentration and activity and urine ACE2/creatinine and activity when moving from the high-Na+ phase to the low-Na+ phase
Day 7 to 14
Change in ACE2 with dietary Na+ intervention while on allopurinol
Time Frame: Day 49 to 56
The change in serum ACE2 concentration and activity and urine ACE2/creatinine and activity when moving from the high-Na+ phase to the low-Na+ phase while on allopurinol
Day 49 to 56
Change in ACE with dietary Na+ intervention
Time Frame: Day 7 to 14
The change in serum ACE concentration and activity and urine ACE2/creatinine and activity when moving from the high-Na+ phase to the low-Na+ phase
Day 7 to 14
Change in ACE with dietary Na+ intervention while on allopurinol
Time Frame: Day 49 to 56
The change in serum ACE concentration and activity and urine ACE2/creatinine and activity when moving from the high-Na+ phase to the low-Na+ phase while on allopurinol
Day 49 to 56
Change in FGF23 with dietary Na+ intervention
Time Frame: Day 7 to 14
The change in serum fibroblast growth factor 23 (FGF23) concentration and urine FGF23/creatinine when moving from the high-Na+ phase to the low-Na+ phase
Day 7 to 14
Change in FGF23 with dietary Na+ intervention while on allopurinol
Time Frame: Day 49 to 56
The change in serum fibroblast growth factor 23 (FGF23) concentration and urine FGF23/creatinine when moving from the high-Na+ phase to the low-Na+ phase while on allopurinol
Day 49 to 56
Neprilysin level at baseline
Time Frame: Day 0
Serum neprilysin concentration and activity and urine neprilysin/creatinine and activity at baseline
Day 0
Change in neprilysin with dietary Na+ intervention
Time Frame: Day 7 to 14
The change in serum neprilysin concentration and activity and urine neprilysin/creatinine and activity when moving from the high-Na+ phase to the low-Na+ phase
Day 7 to 14
Change in neprilysin with dietary Na+ intervention while on allopurinol
Time Frame: Day 49 to 56
The change in serum neprilysin concentration and activity and urine neprilysin/creatinine and activity when moving from the high-Na+ phase to the low-Na+ phase while on allopurinol
Day 49 to 56
Urine albumin at baseline
Time Frame: Day 0
Urine albumin/creatinine at baseline on first-morning urine sample
Day 0
Proportion with albuminuria
Time Frame: Day 0
Albuminuria at baseline, defined as urine albumin/creatinine >30 mg/g on first-morning urine sample
Day 0
Urine protein at baseline
Time Frame: Day 0
Urine protein/creatinine at baseline on first-morning urine sample
Day 0
Proportion with proteinuria
Time Frame: Day 0
Proteinuria at baseline, defined as urine protein/creatinine >0.2 mg/mg on first-morning urine sample
Day 0
Angiotensinogen at baseline
Time Frame: Day 0
Serum angiotensinogen concentration and urine angiotensinogen/creatinine at baseline
Day 0
Change in angiotensinogen with dietary Na+ intervention
Time Frame: Day 7 to 14
The change in serum angiotensinogen concentration and urine angiotensinogen/creatinine when moving from the high-Na+ phase to the low-Na+ phase
Day 7 to 14
Change in angiotensinogen with dietary Na+ intervention while on allopurinol
Time Frame: Day 49 to 56
The change in serum angiotensinogen concentration and urine angiotensinogen/creatinine when moving from the high-Na+ phase to the low-Na+ phase while on allopurinol
Day 49 to 56
24-hour sodium excretion at baseline
Time Frame: Day 0
Sodium excretion in the urine over 24 hours at baseline
Day 0
24-hour potassium excretion at baseline
Time Frame: Day 0
Potassium excretion in the urine over 24 hours at baseline
Day 0
24-hour uric acid excretion at baseline
Time Frame: Day 0
Uric acid excretion in the urine over 24 hours at baseline
Day 0
Pulse wave velocity (CF) at baseline
Time Frame: Day 0
Carotid-femoral (CF) pulse wave velocity will be measured at baseline with the SphygmoCor XCEL device
Day 0
Change in pulse wave velocity (CF) with dietary Na+ intervention
Time Frame: Day 7 to 14
The change in carotid-femoral (CF) pulse wave velocity will be measured with the SphygmoCor XCEL device when moving from high-Na+ phase to the low-Na+ phase
Day 7 to 14
Change in pulse wave velocity (CF) with dietary Na+ intervention while on allopurinol
Time Frame: Day 49 to 56
The change in carotid-femoral (CF) pulse wave velocity will be measured with the SphygmoCor XCEL device when moving from high-Na+ phase to the low-Na+ phase while on allopurinol
Day 49 to 56
Angiotensin II:angiotensin-(1-7) at baseline
Time Frame: Day 0
Plasma and urine angiotensin II:angiotensin-(1-7) at baseline
Day 0
Change in angiotensin II:angiotensin-(1-7) with dietary Na+ intervention
Time Frame: Day 7 to 14
The change in plasma angiotensin II:angiotensin-(1-7) when moving from the high-Na+ phase to the low-Na+ phase
Day 7 to 14
Change in angiotensin II:angiotensin-(1-7) with dietary Na+ intervention while on allopurinol
Time Frame: Day 49 to 56
The change in plasma angiotensin II:angiotensin-(1-7) when moving from the high-Na+ phase to the low-Na+ phase while on allopurinol
Day 49 to 56
ACE:ACE2 at baseline
Time Frame: Day 0
Serum and urine ACE:ACE2 at baseline
Day 0
Change in ACE:ACE2 with dietary Na+ intervention
Time Frame: Day 7 to 14
The change in serum and urine ACE:ACE2 when moving from the high-Na+ phase to the low-Na+ phase
Day 7 to 14
Change in ACE:ACE2 with dietary Na+ intervention while on allopurinol
Time Frame: Day 49 to 56
The change in serum and urine ACE:ACE2 when moving from the high-Na+ phase to the low-Na+ phase while on allopurinol
Day 49 to 56
Body mass index at baseline
Time Frame: Day 0
Body mass index at baseline
Day 0
Proportion with overweight/obesity
Time Frame: Day 0
Overweight/obesity at baseline, defined as a body mass index >=25 kg/m2
Day 0
Proportion with obesity
Time Frame: Day 0
Obesity at baseline, defined as a body mass index >=30 kg/m2
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wake Forest University Health Sciences

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hossam Shaltout, PhD, Wake Forest University Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 2, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 17, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 19, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00057527
  • 1R01HL146818-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD that underlie the results reported in this record, after deidentification.

IPD Sharing Time Frame

Beginning 3 months and ending 5 years following publication.

IPD Sharing Access Criteria

Proposals should be directed to hshaltou@wakehealth.edu. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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