This is a pilot study to determine the feasibility of the study design and examine the main outcome whether low dietary sodium intake is superior to high dietary sodium intake in controlling blood pressure to be within the normotensive range in living kidney donors.
This is a pilot study to determine the feasibility of the study design and examine the main outcome whether low dietary sodium intake \<2.3 g/day (\<100 mmol/day) is superior to high dietary sodium intake ≥4 - \<6 g/day (≥174 - \<261 mmo/day) in controlling blood pressure (BP) to be within normotensive range, lowering systolic and diastolic blood pressures (SBP and DBP) from the baseline blood pressures, and decreasing the risk of hypertension, worsening kidney function, and proteinuria in living kidney donors between 5 and 12 months after living kidney donation?.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
24
Low sodium diet with sodium of \<2.3 g/day (\<100 mmol/day) and high sodium diet with sodium of ≥4 - \<6 g/day (≥174 - \<261 mmo/day)
University of California Irvine Medical Center
Orange, California, United States
Change in systolic and diastolic blood pressure from baseline to post-treatment between the two treatment groups
Change in systolic and diastolic blood pressure from baseline to post-treatment between the two treatment groups, adjusting for patients' demographic and clinical differences (age, gender, BMI, and comorbidities) between the two treatment groups
Time frame: 4 weeks after dietary intervention pre-crossover and 4 weeks after dietary intervention post-crossover
Hypertension
New-onset hypertension defined as systolic blood pressure \>/= 130 or diastolic blood pressure \>/=80 mmHg
Time frame: 4 weeks after dietary intervention pre-crossover and 4 weeks after dietary intervention post-crossover
Worsening kidney function
Increased estimated glomerular filtration rate (eGFR) \>/= 25 ml/min/1.73 m2 or increased serum creatinine \>/= 0.3 mg/dL
Time frame: 4 weeks after dietary intervention pre-crossover and 4 weeks after dietary intervention post-crossover
Worsening proteinuria
Increase in urinary albumin excretion rate (AER) ≥30 mg/day
Time frame: 4 weeks after dietary intervention pre-crossover and 4 weeks after dietary intervention post-crossover
Proteinuria
New-onset urinary albumin excretion rate (AER) ≥30 mg/day
Time frame: 4 weeks after dietary intervention pre-crossover and 4 weeks after dietary intervention post-crossover
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