Health TrialsbyHealthPanel

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

ConditionsSalt; ExcessBlood Pressure Disorders
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age22-33
SponsorWake Forest University Health Sciences

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Singleton birth

Born at less than 34 weeks gestational age (preterm cohort)

Born at greater than 36 weeks gestational age (term cohort)

Disqualifiers

Twin birth

Congenital anomalies or genetic syndromes

Currently pregnant or breast feeding

Subject-reported history of hypertension

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 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.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Preterm GroupExperimental treatment 2 interventions
Group B: Term-born control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Proportion with salt sensitivity of blood pressure at baseline via ABPM

Defined as a ≥8 mmHg decrease in mean arterial blood pressure when moving from the high-Na+ to the low-Na+ phase, as measured on 24-hour ambulatory blood pressure monitoring (ABPM).

Time frame
Day 7 to 14
2

Proportion with salt sensitivity of blood pressure after allopurinol via ABPM

A ≥8 mmHg decrease in mean arterial blood pressure when moving from the high-Na+ to the low-Na+ phase while taking allopurinol, as measured on 24-hour ambulatory blood pressure monitoring (ABPM).

Time frame
Day 49 to 56
3

Salt sensitivity index at baseline

The ratio between the change in 24-hour mean arterial pressure, as measured on 24-hour ambulatory blood pressure monitoring, and the change in 24-hour urine Na+ concentration when moving from the high-Na+ phase to the low-Na+ phase.

Time frame
Day 7 to 14
4

Salt sensitivity index after allopurinol

The ratio between the change in 24-hour mean arterial pressure, as measured on 24-hour ambulatory blood pressure monitoring, and the change in 24-hour urine Na+ concentration when moving from the high-Na+ phase to the low-Na+ phase while taking allopurinol

Time frame
Day 49 to 56

Secondary outcomes

1

Ambulatory systolic blood pressure 24-hour mean at baseline

Average systolic blood pressure over 24 hours, measured with ambulatory blood pressure monitors

Time frame
Day 0
2

Ambulatory diastolic blood pressure 24-hour mean at baseline

Average diastolic blood pressure over 24 hours, measured with ambulatory blood pressure monitors

Time frame
Day 0
3

Ambulatory mean arterial pressure 24-hour mean at baseline

Average mean arterial pressure over 24 hours, measured with ambulatory blood pressure monitors

Time frame
Day 0
4

Ambulatory systolic blood pressure awake mean at baseline

Average systolic blood pressure while awake, measured with ambulatory blood pressure monitors

Time frame
Day 0

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wake Forest University Health Sciences

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov
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