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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-02

Study Completion Date

2026-06-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Salt; Excess Blood Pressure Disorders

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Allopurinol

Intervention Type DRUG

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.

Dietary Intervention

Intervention Type OTHER

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.

Term-born control group

Subjects with birth weight ≥2500 g will receive a dietary intervention (high/low salt diet)

Group Type ACTIVE_COMPARATOR

Dietary Intervention

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type OTHER

Other Intervention Names

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Zyloprim

Eligibility Criteria

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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

Minimum Eligible Age

22 Years

Maximum Eligible Age

33 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes