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

Part of paid clinical trials in Winston-Salem, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT04026776
Phase
EARLY_PHASE1
Status
Recruiting

Conditions

  • Blood Pressure Disorders
  • Salt; Excess

Eligibility Criteria

Sex
ALL
Age
22 Years - 33 Years
Healthy Volunteers
Accepted

Interventions

  • Allopurinol — 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 — 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.

Study Details

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

Key Dates

Start date
Sep 2, 2020
Status verified
Mar 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
120 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

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)

Primary Outcome Measure

Proportion with salt sensitivity of blood pressure at baseline via ABPM [ Time Frame: Day 7 to 14 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Wake Forest University Health SciencesWinston-SalemNorth Carolina27157
Hossam Shaltout, PhD
336-716-1251
Hossam Shaltout, PhD (PRINCIPAL_INVESTIGATOR)
Andrew South, MD, MS (SUB_INVESTIGATOR)

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