Overview

Effectiveness of Urinary Alkalinizing Agents on Kidney Stone Risk

Status:
Enrolling by invitation
Trial end date:
2021-08-01
Target enrollment:
90
Participant gender:
All
Summary
Randomized treatment trial of baking soda, UrocitK, or LithoLyte to determine if baking soda and Litholyte are as effective as UrocitK in raising 24 hour urine citrate and pH.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Wisconsin, Madison
Treatments:
Antacids
Potassium Citrate
Criteria
Inclusion Criteria:

- Must be suitable for the study per clinical judgement of study team members

- Patient in the UW Health University Hospital Urology Clinic or the Metabolic Stone
Clinic

- Had at least one kidney stone event

- Greater than or equal to 18 years of age

- 24 hour urine citrate is less than 420 mg and/or urine pH is less than 5.9

- Urinary alkalinization is deemed by provider as a necessary therapeutic goal for the
subject and may be achieved by any of the three therapies under examination

- Subject is willing to provide consent and to be randomized into a treatment

Exclusion Criteria:

- Subject is deemed unsuitable for urinary alkalinizing therapy by study staff

- Subject is already on a urinary alkalinizing agent

- Subject is on acetazolamide

- Subject reports sensitivity to sugar alcohols

- Subject is under 18 years of age

- Subject has not completed a 24 hour urine collection within 6 months

- Subject is pregnant or breastfeeding

- Subject is unable or unwilling to provide consent

- Subject is unable or unwilling to be randomized

- Subject reports they are unwilling or unable to use measuring device required in the
baking soda arm of the study