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Treating Metabolic Acidosis in Chronic Kidney Disease to Prevent Adverse Kidney and Cardiovascular Outcomes

NCT06545461 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2024-08-09

No results posted yet for this study

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.

Conditions

Interventions

OTHER

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.

OTHER

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.

OTHER

Usual Care

Participants will receive standard medical care but no additional alkali (F+V nor NaHCO3).

Sponsors & Collaborators

  • University of Texas at Austin

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1998-06-22
Primary Completion
2006-10-25
Completion
2016-10-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06545461 on ClinicalTrials.gov