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 — DRUGStudy 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 — OTHERHigh-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 GroupSubjects 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 groupSubjects 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
- Hossam Shaltout, PhD336-716-1251
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | Hossam Shaltout, PhD (PRINCIPAL_INVESTIGATOR) Andrew South, MD, MS (SUB_INVESTIGATOR) |
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