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Xanthine Oxidase Inhibitor

Salt Reduction Diet for High Blood Pressure (PEPC3 Trial)

Phase < 1
Recruiting
Led By Lisa Washburn, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Born at less than 34 weeks gestational age (preterm cohort)
Born at greater than 36 weeks gestational age (term cohort)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 49 to 56
Awards & highlights

PEPC3 Trial Summary

This trial will help researchers learn if reducing salt in the diet can lower blood pressure in young adults who were born prematurely.

Who is the study for?
This trial is for young adults born between 1990-1998, either prematurely (before 34 weeks) or at term (after 36 weeks), who are not twins. Participants should not have high blood pressure, be pregnant or breastfeeding, and must be free of serious conditions like active cancer, chronic kidney disease, liver or heart failure.Check my eligibility
What is being tested?
The study is examining the effects of a drug called Allopurinol and dietary changes on how salt affects blood pressure in young adults who were born preterm. The goal is to understand better ways to manage potential risks associated with premature birth.See study design
What are the potential side effects?
Allopurinol may cause side effects such as rash, digestive issues, and drowsiness. Dietary interventions might lead to temporary discomforts like changes in bowel habits or food cravings.

PEPC3 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I was born before reaching 34 weeks of pregnancy.
Select...
I was born after 36 weeks of pregnancy.
Select...
I was born between 1990 and 1998.

PEPC3 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 49 to 56
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 49 to 56 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Angiotensin II at baseline
Angiotensin-(1-7) at baseline
Augmentation index at baseline
+20 more
Secondary outcome measures
24-hour potassium excretion at baseline
24-hour sodium excretion at baseline
24-hour uric acid excretion at baseline
+64 more

Side effects data

From 2019 Phase 3 trial • 530 Patients • NCT02017171
16%
Rash
12%
Upper respiratory tract infection
10%
Hypoglycaemia
7%
Nasopharyngitis
6%
Urinary tract infection
6%
Influenza like illness
6%
Sinusitis
6%
Diabetic ketoacidosis
5%
Pain in extremity
4%
Bronchitis
3%
Acute myocardial infarction
2%
Osteomyelitis
2%
Abortion spontaneous
1%
Diarrhoea
1%
Myocardial infarction
1%
Cardiac failure congestive
1%
Diabetic gastroparesis
1%
Chest pain
1%
Pancreatitis acute
1%
Asthma
1%
Coronary artery disease
1%
Gastrointestinal haemorrhage
1%
Pneumonia
1%
Cardiac arrest
1%
Hyperglycaemia
1%
Death
1%
Cellulitis
1%
Staphylococcal infection
1%
Road traffic accident
1%
Renal failure acute
1%
Pregnancy
1%
Skin ulcer
1%
Amputation
1%
Hyperemesis gravidarum
1%
Angina unstable
1%
Impaired gastric emptying
1%
Cerebrovascular accident
100%
80%
60%
40%
20%
0%
Study treatment Arm
Allopurinol
Placebo

PEPC3 Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Preterm GroupExperimental Treatment2 Interventions
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
Group II: Term-born control groupActive Control1 Intervention
Subjects with birth weight ≥2500 g will receive a dietary intervention (high/low salt diet)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Allopurinol
1999
Completed Phase 4
~6150

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,242 Previous Clinical Trials
1,004,102 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,837 Previous Clinical Trials
47,851,429 Total Patients Enrolled
Lisa Washburn, MDPrincipal InvestigatorWake Forest University Health Sciences

Media Library

Allopurinol (Xanthine Oxidase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04026776 — Phase < 1
High Blood Pressure Research Study Groups: Term-born control group, Preterm Group
High Blood Pressure Clinical Trial 2023: Allopurinol Highlights & Side Effects. Trial Name: NCT04026776 — Phase < 1
Allopurinol (Xanthine Oxidase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04026776 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any elderly individuals being considered as participants in this experiment?

"This experimental trial is open to applicants between the ages of 24 and 32. Prospective participants under 18 or over 65 can look at 84 studies available for them, respectively 163 trials."

Answered by AI

Is there capacity within this trial to accept new participants?

"Indeed, clinicaltrials.gov attests that this trial is still looking for people to join it. This research project was first advertised on September 2nd 2020 and most recently updated on July 20th 2022. It requires 165 participants from one location."

Answered by AI

What is the maximum number of participants being allowed to join this medical trial?

"Indeed, clinicaltrials.gov has reported that recruitment for this medical trial is actively taking place. Initially announced on September 2nd 2020, the study now seeks 165 participants from a single site and was recently updated on July 20th 2022."

Answered by AI

Are there any additional investigations which have utilized Dietary Intervention?

"Currently, 9 active clinical trials are evaluating the efficacy of Dietary Intervention with 4 being in Phase 3. Gainesville, Florida is hosting several studies on this topic but there are 25 other locations conducting research as well."

Answered by AI

Are there any age or health restrictions for participants of this trial?

"This research trial is searching for 165 individuals between the ages 24 and 32, diagnosed with hypertension. In addition to these criteria, participants must have been birthed singly in the years 1990-1998; preterm births should be no later than 34 weeks gestation while term birth dates should exceed 36 weeks gestational age."

Answered by AI

What is the core purpose of this clinical investigation?

"This medical trial, monitored between Day 49 and 56, will primarily focus on Angiotensin-(1-7) at the start of the study. Additionally, Ambulatory diastolic blood pressure asleep mean at baseline, Ambulatory systolic blood pressure nocturnal dipping at baseline, as well as Change in pulse wave velocity with dietary Na+ intervention while on allopurinol shall be observed during this period."

Answered by AI

What conditions most commonly benefit from Dietary Intervention?

"Dietary Intervention is a popular treatment for gout flares, but its utility extends beyond that. It can be taken to help manage several other illnesses such as malignancies, kidney diseases and Lesch-Nyhan syndrome."

Answered by AI

Who else is applying?

What state do they live in?
Nevada
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Uric Acid, Klotho and Salt Sensitivity in Young Adults Born Preterm
2020. "Uric Acid, Klotho and Salt Sensitivity in Young Adults Born Preterm". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04026776.
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