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Dietary Acid Reduction and Progression of Chronic Kidney Disease

NCT06046924 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 153

Last updated 2023-09-21

No results posted yet for this study

Summary

Upon completion, this project will determine if dietary acid reduction done with either fruits and vegetables (F+V) or the medication sodium bicarbonate (NaHCO3) in study participants with high blood pressure (hypertension) and initially normal kidney function but with signs of kidney injury 1) slows progression of chronic kidney disease (CKD); 2) improves indices of cardiovascular risk; and 3) better preserves acid-base status. These studies are designed to determine if the simple and comparatively inexpensive intervention of dietary acid reduction can prevent or reduce adverse outcomes in individuals with early-stage CKD.

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/day for each participant randomized to this group, depending on the type of F+Vs used, provided in weekly allotments. Participants will receive standard care for their medical concerns.

DRUG

NaHCO3 Tablets

Participants will receive 0.4 mEq/kg bw NaHCO3 /day, an amount designed to match the alkali provided by the added F+V. This will be provided as 650 mg NaHCO3 tablets for an average of 4-5 tablets/day in 2 divided doses for each participant randomized to this group. Participants will receive standard care for their medical concerns.

OTHER

Usual Care

Participants will receive standard care for their medical concerns and no additional alkali (F+V or NaHCO3).

Sponsors & Collaborators

  • University of Texas at Austin

    lead OTHER

Principal Investigators

  • Donald Wesson · Donald E Wesson Consulting LLC

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
1996-06-24
Primary Completion
2006-11-15
Completion
2011-12-15

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Entities

Diseases

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 NCT06046924 on ClinicalTrials.gov