Sodium Bicarbonate as an Alternative to Potassium Citrate for Kidney Stones

ConditionsKidney Stones, Urolithiasis, Hypocitraturia Nephrolithiasis

Trial statusNot yet recruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity of California, Los Angeles

About this trial

Kidney stones affect 1 in every 11 people in the US each year. In patients with kidney stones who are prescribed medications for stone management, only 30.2% are adherent to a medication regime and even fewer, only 13.4 % are adherent with citrate medications.

Prescription potassium citrate can be expensive for many patients, leading to non-compliance. Sodium bicarbonate is a potential medication alternative that is cheaper and can potentially alkalinize the urine and/or decrease the risk of future kidney stones. However, efficacy of alternatives to potassium potassium citrate are not well studied.

This study seeks to evaluate sodium bicarbonate and assess its ability to alkalinize urine in a cohort of patients with kidney stones and compare this to prescription potassium citrate.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult >18 years of age

History of nephrolithiasis

One 24h urine collections within one year of enrollment with hypocitraturia.

Patients currently utilizing or considering use of Kcit for stone prevention

Disqualifiers

Individuals with known metabolic disorders

Individuals with other known causes of nephrolithiasis

Anyone who, in the opinion of the PI, is unfit or unsuitable to participate in the study

Trial design

Design model

Crossover

Treatments tested in this trial

Potassium Citrate
Drug
20 mEq Kcit twice a day (40 mEq daily
Sodium Bicarbonate
Drug
650 mg sodium bicarbonate twice a day (35.2 mEq daily)

Treatment groups

30 Participants

are divided into 2 treatment groups

Group A: Sodium Bicarbonate -> Potassium CitrateExperimental treatment 2 interventions

Group B: Potassium Citrate -> Sodium BicarbonateExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

Change in 24-Hour Urinary Citrate Excretion from 24-Hour Urine Collection

Change in 24-hour urinary citrate excretion measured from 24-hour urine collections obtained at baseline and after intervention. To determine if sodium bicarbonate is not significantly worse than potassium citrate by more than a clinically acceptable margin of -10 Unit: mg/day

Time frame

14 days

Secondary outcomes

Change in Urine pH Measured from 24-Hour Urine Collection

Change in urine pH measured from 24 hour urine collections obtained at baseline and after intervention units: pH

Time frame

14 days

Change in 24 hour Urinary Ammonia Excretion from 24 Hour Urine Collection

Change in 24 hour urinary ammonia excretion from 24 hour urine collections obtained at baseline and after intervention Unit: mmol/day

Time frame

14 days

Other outcomes

Incidence of Side Effects

Number of participants experiencing side effects attributed to the intervention Unit: number of participants with ≥1 adverse event

Time frame

14 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, Los Angeles

Lead sponsor

University of California, Davis

Collaborator

Brigham and Women's Hospital

Collaborator

Landspitali University Hospital

Collaborator

University of California, San Diego

Collaborator

Centre hospitalier de l'Université de Montréal (CHUM)

Collaborator

Source ClinicalTrials.gov

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