Effectiveness of Urinary Alkalinizing Agents on Kidney Stone Risk

Completed · Phase 4

Conditions studied: Kidney Stone

In brief

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.

Key facts

Study ID

NCT04095975

Run by

University of Wisconsin, Madison

People needed

31

Starts

2019-08-28

Expected to finish

2021-06-24

Last updated by the study team

2021-11-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UW-Madison — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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