RecruitingEarly Phase 1

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

United States120 participantsStarted 2020-09-02

Plain-language summary

The purpose of this research is to learn about how salt in the diet influences blood pressure in young adults who were born prematurely.

Who can participate

Age range

22 Years – 33 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since this is an Early Phase 1 study focused on measuring and understanding blood pressure patterns in young adults born preterm — rather than testing a proven treatment — what does that mean for what my doctor and I might actually learn from my participation?
2The trial uses allopurinol, a drug that lowers uric acid, to see if it changes salt sensitivity of blood pressure — given that allopurinol isn't typically used for blood pressure, what are the known risks or side effects I should be aware of before considering this?
3The study involves switching between high-salt and low-salt diets while wearing a blood pressure monitor for extended periods — is that kind of dietary and monitoring commitment realistic given my current health situation and daily schedule?
4Since the trial is measuring things like kidney function markers, arterial stiffness, and hormone levels at baseline, would my doctor be able to share those results with me, and could they actually inform my personal care plan outside the study?
5If it turns out I do show salt sensitivity of blood pressure through this study, would that finding change what treatment or lifestyle options my doctor might recommend, or is standard care already the better path to address my blood pressure concerns right now?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Proportion with salt sensitivity of blood pressure at baseline via ABPM

Timeframe: Day 7 to 14

Proportion with salt sensitivity of blood pressure after allopurinol via ABPM

Timeframe: Day 49 to 56

Salt sensitivity index at baseline

Timeframe: Day 7 to 14

Salt sensitivity index after allopurinol

Timeframe: Day 49 to 56

Proportion with salt sensitivity of blood pressure at baseline via casual blood pressure

Timeframe: Day 7 to 14

Proportion with salt sensitivity of blood pressure after allopurinol via casual blood pressure

Timeframe: Day 49 to 56

High blood pressure at baseline via ABPM

Timeframe: Day 0

Trial details

NCT IDNCT04026776

SponsorWake Forest University Health Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12

Contact for this trial

Hossam Shaltout, PhD

336-716-1251 Hossam.Shaltout@advocatehealth.org

View on ClinicalTrials.gov More Salt; Excess trials

Who can participate

Age range

22 Years – 33 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Proportion with salt sensitivity of blood pressure at baseline via ABPM

Timeframe: Day 7 to 14

Proportion with salt sensitivity of blood pressure after allopurinol via ABPM

Timeframe: Day 49 to 56

Salt sensitivity index at baseline

Timeframe: Day 7 to 14

Salt sensitivity index after allopurinol

Timeframe: Day 49 to 56

Proportion with salt sensitivity of blood pressure at baseline via casual blood pressure

Timeframe: Day 7 to 14

Proportion with salt sensitivity of blood pressure after allopurinol via casual blood pressure

Timeframe: Day 49 to 56

High blood pressure at baseline via ABPM

Timeframe: Day 0