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Treating Metabolic Acidosis in Chronic Kidney Disease to Prevent Adverse Kidney and Cardiovascular Outcomes
Sponsor: Donald Wesson
Summary
Upon completion, this project will determine if treatment of metabolic acidosis in non-diabetic study participants with reduced kidney function (chronic kidney disease \[CKD\] stage 3) associated with high blood pressure (hypertension) and macroalbuminuria, the latter indicating pronounced kidney injury, using either base-producing fruits and vegetables (F+V) or standard therapy for treatment of metabolic acidosis with the medication sodium bicarbonate (NaHCO3) 1) slows progression of CKD toward end-stage renal disease \[ESRD\]; 2) improves indices of cardiovascular disease (CVD) risk; and 3) better preserves plasma acid-base parameters. These studies are designed to compare the differential effects of treating the metabolic acidosis of CKD with F+Vs or NaHCO3 on kidney outcomes, including progression to ESRD, on indices of CVD risk and on plasma acid-base parameters.
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
108
Start Date
1998-06-22
Completion Date
2016-10-30
Last Updated
2026-06-12
Healthy Volunteers
No
Interventions
Fruits and Vegetables (F+V)
Participants will receive a prescribed amount of F+V designed to reduce their dietary acid intake by half. This typically amounts to 2-4 cups daily of F+V provided in weekly allotments. Amount provided will be that calculated for the participant multiplied times number of household members to assure participants eat the prescribed amount and do not share with household members.
Sodium Bicarbonate (NaHCO3)
Participants will receive 0.3 mEq/kg bw/day NaHCO3 tablets to match the alkali provided by F+V given to F+V participants. This will be provided as 650 mg NaHCO3 tablets for an average of 4-5 tablets/day in two divided oral doses.
Usual Care
Participants will receive standard medical care but no additional alkali (F+V nor NaHCO3).