Effectiveness of Urinary Alkalinizing Agents on Kidney Stone Risk

Kidney Stone Clinical Trial

Official title: Effectiveness of Prescription vs. Non-prescription Urinary Alkalinizing Agents on Kidney Stone Risk

Status Completed

Clinical Trial 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.

Clinical Trial 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 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 baking soda will be provided instructions for using baking soda to provide 40 mEq alkali, to be accomplished by dissolving ¼ teaspoon baking soda in water or other beverage (any amount) in the morning on an empty stomach and ½ teaspoon baking soda in water or other beverage again at bedtime, also on an empty stomach.

The 24-hour urine results that are available upon enrollment will be used for pre-intervention values. The 24-hour results from each participant's followup collection will be used for post-intervention values. Thus, no extra encounters are required for participation in the study. Additionally, no extra tests are required for participation in the study as participants would normally complete a post-treatment 24-hour urine collection anyway. Participants will be screened for eligibility, i.e., by pre-clinic review of schedules and 24-hour urine results. Only those meeting inclusion criteria will be invited to participate and enrolled, provided that informed consent is provided by signing the signature page of the consent/authorization form. The treatment/intervention period is up to 90 days (approximately 3 months). However, it should be noted that, as these are clinical interventions that would be prescribed or recommended anyway, it is expected that participants will continue treatment indefinitely and under supervision of urology and/or Metabolic Stone Clinic providers. If the participant has failed the randomized therapy they are assigned to, they will be clinically assigned a different treatment option and continue to be followed up in routine fashion.

Participants will also be asked to complete a medication questionnaire and log, as well as the Wisconsin Stone Quality of Life (WISQOL) questionnaire. All study procedures are considered standard of care, except for: randomization into treatment and the medication questionnaire and log.

Protocol Amendment Approved 11/16/2020 removed the UrocitK study arm; the investigators faced challenges recruiting participants during the COVID-19 pandemic and the possibility of being randomized into a prescription drug arm was causing many potential participants to choose not to participate. ;

Related Conditions & MeSH terms

• Kidney Calculi
• Kidney Stone
• Nephrolithiasis

• NCT number: NCT04095975
• Study type: Interventional
• Source: University of Wisconsin, Madison
• Status: Completed
• Phase: Phase 4
• Start date: August 28, 2019
• Completion date: June 24, 2021