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

Last updated: May 8, 2025
Sponsor: University of Texas Southwestern Medical Center
Overall Status: Active - Not Recruiting

Phase

1

Condition

N/A

Treatment

Sodium bicarbonate

Crystal Lite

Potassium Bicarbonate

Clinical Study ID

NCT04651088
STU-2020-0613
  • Ages 18-90
  • All Genders
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adults aged 18 and older.

  • with or without a history of stone disease.

Exclusion

Exclusion Criteria:

  • They are unable to take any of the medications due to health reasons.

  • Participants are pregnant or nursing.

  • Participants are unable to adhere to the metabolic diet.

  • Participants had a prior adverse event from one or more of the medications.

Study Design

Total Participants: 15
Treatment Group(s): 5
Primary Treatment: Sodium bicarbonate
Phase: 1
Study Start date:
September 01, 2025
Estimated Completion Date:
July 31, 2026

Study Description

Kidney stones are a common medical problem, occurring in almost 10% of people in the United States1. Furthermore, 50% of patients will recur within 10 years2. Metabolic testing is advised in recurrent stone formers, as well as those considered high risk, to assess for a specific abnormality which may prompt intervention to prevent future stone formation. Non-surgical interventions include both dietary counselling, as well as pharmacotherapy.

One of the most commonly prescribed class of pharmacotherapies is alkali therapy which can be used to both increase the urinary pH and raise the urine citrate levels. This is particularly useful as correction of very acidic urinary pH (<5.5) can counteract uric acid crystallization thereby preventing or even dissolving uric acid stones3. Further, citrate has been shown to be a potent inhibitor of calcium stones by binding to the calcium directly4 and inhibiting crystal nucleation, thereby reducing calcium stone formation5,6.

The most commonly utilized preparation of alkali therapy is potassium citrate which has been shown to prevent stone formation better than sodium citrate7. Unfortunately, some forms of potassium citrate (crystal packets) have become unavailable, and the slow release form of potassium citrate (UroCit-K) now exceeds $15/day in cost8. There have been multiple alternative alkali therapies that have been used in place of potassium citrate, including both medical foods and prescription medications, but with little evidence to support their use. A pilot study in order to quantify the metabolic effects of these agents and compare them to potassium citrate will be performed.

Connect with a study center

  • University of Texas Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Site Not Available

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