Sodium Bicarbonate as an Alternative to Potassium Citrate for Kidney Stones
1 other identifier
interventional
30
3 countries
6
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Feb 2026
Typical duration for phase_1
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 16, 2026
CompletedStudy Start
First participant enrolled
February 1, 2026
CompletedFirst Posted
Study publicly available on registry
February 12, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2028
February 12, 2026
January 1, 2026
6 months
January 16, 2026
February 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
14 days
Secondary Outcomes (2)
Change in Urine pH Measured from 24-Hour Urine Collection
14 days
Change in 24 hour Urinary Ammonia Excretion from 24 Hour Urine Collection
14 days
Other Outcomes (1)
Incidence of Side Effects
14 days
Study Arms (2)
Sodium Bicarbonate -> Potassium Citrate
EXPERIMENTALReceives 1 week of sodium bicarbonate, then 1 week of potassium citrate after washout.
Potassium Citrate -> Sodium Bicarbonate
EXPERIMENTAL1 week of potassium citrate first, then sodium bicarbonate after a washout.
Interventions
20 mEq Kcit twice a day (40 mEq daily
650 mg sodium bicarbonate twice a day (35.2 mEq daily)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of California, Los Angeleslead
- University of California, Daviscollaborator
- Brigham and Women's Hospitalcollaborator
- Landspitali University Hospitalcollaborator
- University of California, San Diegocollaborator
- Centre hospitalier de l'Université de Montréal (CHUM)collaborator
Study Sites (6)
University of California, Los Angeles
Los Angeles, California, 90095, United States
University of California, Davis
Sacramento, California, 95817, United States
University of California, San Diego
San Diego, California, 92103, United States
Brigham & Women's
Boston, Massachusetts, 02115, United States
CHUM
Montreal, Canada
Landspitali- National University Hospital of Iceland
Reykjavik, Iceland
Related Publications (9)
Xue W, Cheng J, Zhao J, Wang L, Peng A, Liu X. Comparison potassium sodium hydrogen citrate with sodium bicarbonate in urine alkalization: a prospective crossover-controlled trial. Int Urol Nephrol. 2023 Jan;55(1):61-68. doi: 10.1007/s11255-022-03387-y. Epub 2022 Oct 19.
PMID: 36261757BACKGROUNDPinheiro VB, Baxmann AC, Tiselius HG, Heilberg IP. The effect of sodium bicarbonate upon urinary citrate excretion in calcium stone formers. Urology. 2013 Jul;82(1):33-7. doi: 10.1016/j.urology.2013.03.002. Epub 2013 Apr 18.
PMID: 23602798BACKGROUNDDauw CA, Yi Y, Bierlein MJ, Yan P, Alruwaily AF, Ghani KR, Wolf JS Jr, Hollenbeck BK, Hollingsworth JM. Factors Associated With Preventive Pharmacological Therapy Adherence Among Patients With Kidney Stones. Urology. 2016 Jul;93:45-9. doi: 10.1016/j.urology.2016.03.030. Epub 2016 Mar 31.
PMID: 27041472BACKGROUNDPearle MS, Goldfarb DS, Assimos DG, Curhan G, Denu-Ciocca CJ, Matlaga BR, Monga M, Penniston KL, Preminger GM, Turk TM, White JR; American Urological Assocation. Medical management of kidney stones: AUA guideline. J Urol. 2014 Aug;192(2):316-24. doi: 10.1016/j.juro.2014.05.006. Epub 2014 May 20.
PMID: 24857648BACKGROUNDPearle MS, Roehrborn CG, Pak CY. Meta-analysis of randomized trials for medical prevention of calcium oxalate nephrolithiasis. J Endourol. 1999 Nov;13(9):679-85. doi: 10.1089/end.1999.13.679.
PMID: 10608521BACKGROUNDBarcelo P, Wuhl O, Servitge E, Rousaud A, Pak CY. Randomized double-blind study of potassium citrate in idiopathic hypocitraturic calcium nephrolithiasis. J Urol. 1993 Dec;150(6):1761-4. doi: 10.1016/s0022-5347(17)35888-3.
PMID: 8230497BACKGROUNDEttinger B, Pak CY, Citron JT, Thomas C, Adams-Huet B, Vangessel A. Potassium-magnesium citrate is an effective prophylaxis against recurrent calcium oxalate nephrolithiasis. J Urol. 1997 Dec;158(6):2069-73. doi: 10.1016/s0022-5347(01)68155-2.
PMID: 9366314BACKGROUNDUribarri J, Oh MS, Carroll HJ. The first kidney stone. Ann Intern Med. 1989 Dec 15;111(12):1006-9. doi: 10.7326/0003-4819-111-12-1006.
PMID: 2688503BACKGROUNDScales CD Jr, Smith AC, Hanley JM, Saigal CS; Urologic Diseases in America Project. Prevalence of kidney stones in the United States. Eur Urol. 2012 Jul;62(1):160-5. doi: 10.1016/j.eururo.2012.03.052. Epub 2012 Mar 31.
PMID: 22498635BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kymora B Scotland, MD, PhD
University of California, Los Angeles
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
January 16, 2026
First Posted
February 12, 2026
Study Start
February 1, 2026
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
February 1, 2028
Last Updated
February 12, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Starting 6 months after publication Ending 3 years after publication
- Access Criteria
- Researchers who submit a research proposal with justified rationale for why they need to access the data along with sound methodological approach, pending approval by the corresponding author. De-identified IPD (ie. baseline characteristics, outcomes, and adverse events) reported from this study will be made available along with study protocol and statistical analysis plan.
De-identified individual participant data that underlie the results reported in this study, along with the Study Protocol and Statistical Analysis Plan, will be made available to qualified researchers upon request. Interested parties should direct their inquiries and research proposals to KScotland@mednet.ucla.edu. To gain access, requestors will be required to provide a methodologically sound proposal and sign a formal Data Use Agreement (DUA) to ensure participant confidentiality. Data will be available beginning 6 months after the publication of the primary results and will remain accessible for a period of 3 years. The study team will review all requests to determine if the proposed use of the data aligns with the original study's ethical approvals and scientific objectives.