Effectiveness of Urinary Alkalinizing Agents on Kidney Stone Risk
Launched by UNIVERSITY OF WISCONSIN, MADISON · Sep 17, 2019
Trial Information
Current as of May 13, 2025
Completed
Keywords
ClinConnect Summary
Participants will not be required to attend any study visits outside of normal clinical encounters. Participants enrolled in the study will be randomized to treatment upon enrollment. Blocked randomization will be conducted, utilizing sex (M/F) and recurrent stone former (Y/N) as algorithm variables.
Participants randomized to LithoLyte® will be provided 40 mEq of alkali in the form of LithoLyte® and advised to take 20 mEq twice daily according to package instructions, once in morning and once at bedtime; no requirements about proximity to meals are necessary.
Participants randomized to b...
Gender
ALL
Eligibility 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
About University Of Wisconsin, Madison
The University of Wisconsin-Madison is a leading research institution renowned for its commitment to advancing healthcare through innovative clinical trials. With a strong emphasis on interdisciplinary collaboration, the university leverages its extensive resources, including cutting-edge facilities and a diverse pool of expert researchers, to conduct rigorous studies that address critical health challenges. The institution's focus on translating research findings into practical applications fosters the development of new treatments and interventions, ultimately contributing to improved patient outcomes and public health initiatives. As a sponsor of clinical trials, the University of Wisconsin-Madison is dedicated to upholding the highest ethical standards and ensuring participant safety throughout the research process.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Madison, Wisconsin, United States
Patients applied
Trial Officials
Kristina L Penniston, PhD, RDN, FAND
Principal Investigator
University of Wisconsin, Madison
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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