Status:
COMPLETED
Effectiveness of Urinary Alkalinizing Agents on Kidney Stone Risk
Lead Sponsor:
University of Wisconsin, Madison
Conditions:
Kidney Stone
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Randomized treatment trial of baking soda or LithoLyte to determine if baking soda and Litholyte are effective in raising 24 hour urine citrate and pH.
Detailed Description
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 randomiz...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 28 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 24 2021
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT04095975
Start Date
August 28 2019
End Date
June 24 2021
Last Update
November 22 2021
Active Locations (1)
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1
UW-Madison
Madison, Wisconsin, United States, 53726