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Comparing Alkalinizing Agents Efficacy on Stone Risk in Patients on a Metabolically Controlled Diet

NCT04651088 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-02-13

No results posted yet for this study

Summary

The purpose of this study is to compare over the counter and alternative prescription urinary alkalinizing agents to slow release potassium citrate in their ability to modify urinary parameters associated with stone formation.

Conditions

  • Kidney Stone

Interventions

DRUG

Potassium citrate

Slow release potassium citrate UroCit-K. Participants will take 20mEq twice daily.

DRUG

Sodium bicarbonate

650mg tabs. Take 3 tabs twice daily.

DIETARY_SUPPLEMENT

Litholyte

One packet is taken with 170ml of water. Two packets daily.

DIETARY_SUPPLEMENT

Crystal Lite

The classic lemonade contains 21.7mEq/liter of alkali Therefore, patients will take 2 litres daily to have the 40mEq of alkali daily needed.

DRUG

Potassium Bicarbonate

20 mEq tablets, one tablet twice daily

Sponsors & Collaborators

  • University of Texas Southwestern Medical Center

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2026-12-31
Completion
2027-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT04651088 on ClinicalTrials.gov