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NCT Number: NCT04651088

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

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location contact

Brett Johnson, MD

CONTACT

[email protected]

2146486853

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged 18 and older.
  • with or without a history of stone disease.

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.

Treatment and study plan

potassium citrate

Drug

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

Sodium bicarbonate

Drug

650mg tabs. Take 3 tabs twice daily.

LithoLyte

Dietary Supplement

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

Crystal Lite

Dietary Supplement

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

Potassium Bicarbonate

Drug

20 mEq tablets, one tablet twice daily

Primary outcomes

  1. 24 hour urine volume

    Time frame: Change from baseline (Day 4) to initial start on treatment (Day 5)

    Total urine volume

  2. 24 hour urine volume

    Time frame: Change from baseline (Day 4) to end of study (day 12)

    Total urine volume

  3. 24 hour urine creatinine

    Time frame: Change from baseline (Day 4) to initial start on treatment (Day 5)

    Urine creatinine

  4. 24 hour urine creatinine

    Time frame: Change from baseline (Day 4) to end of study (day 12)

    Urine creatinine

  5. 24 hour urine calcium

    Time frame: Change from baseline (Day 4) to initial start on treatment (Day 5)

    urine calcium

  6. 24 hour urine calcium

    Time frame: Change from baseline (Day 4) to end of study (day 12)

    urine calcium

  7. 24 hour urine potassium

    Time frame: Change from baseline (Day 4) to initial start on treatment (Day 5)

    Urine potassium

  8. 24 hour urine potassium

    Time frame: Change from baseline (Day 4) to end of study (day 12)

    Urine potassium

  9. 24 hour urine sodium

    Time frame: Change from baseline (Day 4) to initial start on treatment (Day 5)

    Urine sodium

  10. 24 hours urine sodium

    Time frame: Change from baseline (Day 4) to end of study (day 12)

    Urine sodium

  11. 24 hours urine citrate

    Time frame: Change from baseline (Day 4) to initial start on treatment (Day 5)

    Urine citrate

  12. 24 hours urine citrate

    Time frame: Change from baseline (Day 4) to end of study (day 12)

    Urine citrate

  13. 24 hours urine uric acid

    Time frame: Change from baseline (Day 4) to initial start on treatment (Day 5)

    Urine uric acid

  14. 24 hours urine uric acid

    Time frame: Change from baseline (Day 4) to end of study (day 12)

    Urine Uric Acid

  15. 24 hours urine oxalate

    Time frame: Change from baseline (Day 4) to initial start on treatment (Day 5)

    Urine oxalate

  16. 24 hours urine oxalate

    Time frame: Change from baseline (Day 4) to end of study (day 12)

    Urine oxalate

  17. 24 hours urine magnesium

    Time frame: Change from baseline (Day 4) to initial start on treatment (Day 5)

    Urine magnesium

  18. 24 hours urine magnesium

    Time frame: Change from baseline (Day 4) to end of study (day 12)

    Urine magnesium

  19. 24 hours urine ammonia

    Time frame: Change from baseline (Day 4) to initial start on treatment (Day 5)

    Urine ammonia

  20. 24 hours urine ammonia

    Time frame: Change from baseline (Day 4) to end of study (day 12)

    Urine ammonia

  21. 24 Hour Urine pH

    Time frame: Change from baseline (Day 4) to initial start on treatment (Day 5)

    Overal Urine pH from 24h urine sample.

  22. 24 Hour Urine pH

    Time frame: Change from baseline (Day 4) to end of study (day 12)

    Overal Urine pH from 24h urine sample.

  23. 24 hour urine phosphorus

    Time frame: Change from baseline (Day 4) to initial start on treatment (Day 5)

    Urine phosphorus

  24. 24 hour urine phosphorus

    Time frame: Change from baseline (Day 4) to end of study (day 12)

    Urine phosphorus

  25. 24 hour urine sulfate

    Time frame: Change from baseline (Day 4) to initial start on treatment (Day 5)

    Urine sulfate

  26. 24 hour urine sulfate

    Time frame: Change from baseline (Day 4) to end of study (day 12)

    Urine sulfate

Secondary outcomes

  1. # of patient who adherence to 100% Medication

    Time frame: At the end of study approximately 10 weeks after start of study.

    Patient's adherence to medication for duration of study.

  2. Total out of pocket cost

    Time frame: At the end of study approximately 10 weeks after start of study.

    Calculate and compare treatment costs for the different interventions (in American dollars).

  3. Patient's Satisfaction Survey

    Time frame: At the end of study approximately 10 weeks after start of study.

    Patient satisfaction survey, adapted from the Treatment Satisfaction Questionnaire for Medication-14. Patients are queried on their satisfaction, with 9 questions for each medication.

  4. Patient's GI Distress

    Time frame: At the end of study approximately 10 weeks after start of study.

    Patient's GI distress symptom scale measures patients GI distress. There are 18 questions with descriptive answers ranging from "none", "mild", "moderate", "quite a lot" and "unbearable". There are no numerical scores, rather just descriptive scores. "None" means no GI distress, "unbearable" means that you are in a lot of distress from your GI symptoms.

Study contacts

Contact information is provided by the study sponsor or research team.

Ashley Gonzalez, MD

CONTACT

[email protected]

Brett A Johnson, MD

CONTACT

[email protected]

214-648-6853

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study title

Evaluation of Multiple Alkalinizing Agents on Urinary Stone Risk Parameters in Stone and Non-stone Formers on a Metabolically Controlled Diet

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Dec 3, 2020
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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