Recruiting
Early Phase 1

Observational Study

Sponsor:

Wake Forest University Health Sciences

Code:

NCT04026776

Conditions

Salt; Excess

Blood Pressure Disorders

Eligibility Criteria

Sex: All

Age: 22 - 33

Healthy Volunteers: Accepted

Interventions

Allopurinol

Dietary Intervention

Study Details

Brief 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.

Conditions

Salt; Excess

Blood Pressure Disorders

Study ID

NCT04026776

Start date

Sep 2, 2020

Status verified date

Mar, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22 - 33

Healthy Volunteers: Accepted

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 Design

Enrollment

120 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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

active comparator: Term-born control group

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

Interventions

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.

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.

Primary outcome measure

  • Proportion with salt sensitivity of blood pressure at baseline via ABPM [ Time Frame: Day 7 to 14 ]
  • Proportion with salt sensitivity of blood pressure after allopurinol via ABPM [ Time Frame: Day 49 to 56 ]
  • Salt sensitivity index at baseline [ Time Frame: Day 7 to 14 ]
  • Salt sensitivity index after allopurinol [ Time Frame: Day 49 to 56 ]
  • Proportion with salt sensitivity of blood pressure at baseline via casual blood pressure [ Time Frame: Day 7 to 14 ]
  • Proportion with salt sensitivity of blood pressure after allopurinol via casual blood pressure [ Time Frame: Day 49 to 56 ]
  • High blood pressure at baseline via ABPM [ Time Frame: Day 0 ]
  • Hypertension at baseline via ABPM [ Time Frame: Day 7 ]
  • High blood pressure at baseline via casual blood pressure [ Time Frame: First 3 study visits ]
  • Hypertension at baseline via casual blood pressure [ Time Frame: First 3 study visits ]
  • Serum uric acid at baseline [ Time Frame: Day 0 ]
  • Change in serum uric acid with dietary Na+ intervention [ Time Frame: Day 7 to 14 ]
  • Change in serum uric acid with dietary Na+ intervention on allopurinol [ Time Frame: Day 42 to 56 ]
  • Pulse wave velocity at baseline [ Time Frame: Day 0 ]
  • Augmentation index at baseline [ Time Frame: Day 0 ]
  • Heart rate variability at baseline [ Time Frame: Day 0 ]
  • Baroreflex sensitivity at baseline [ Time Frame: Day 0 ]
  • Angiotensin-(1-7) at baseline [ Time Frame: Day 0 ]
  • Angiotensin II at baseline [ Time Frame: Day 0 ]
  • Klotho at baseline [ Time Frame: Day 0 ]
  • Creatinine at baseline [ Time Frame: Day 0 ]
  • Cystatin C at baseline [ Time Frame: Day 0 ]
  • eGFR at baseline [ Time Frame: Day 0 ]

Central Contacts and Locations

Central contacts

Hossam Shaltout, PhD

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

Locations

Wake Forest University Health Sciences

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Hossam Shaltout, PhD

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

Principal Investigator:

Hossam Shaltout, PhD

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Jun 29, 2026

Last verified

Mar, 2026

Keywords

  • Uric Acid sensitivity
  • Salt sensitivity
  • Blood Pressure Influences

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-06-29.