Effectiveness of Urinary Alkalinizing Agents on Kidney Stone Risk
NCT ID: NCT04095975
Last Updated: 2021-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
31 participants
INTERVENTIONAL
2019-08-28
2021-06-24
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Baking Soda
Subjects 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.
Baking Soda
Standard baking soda that can be bought from stores.
LithoLyte
Subjects 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.
LithoLyte
LithoLyte is considered a medical food and consists of: potassium citrate, magnesium citrate, sodium bicarbonate, and erythritol.
Interventions
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Baking Soda
Standard baking soda that can be bought from stores.
LithoLyte
LithoLyte is considered a medical food and consists of: potassium citrate, magnesium citrate, sodium bicarbonate, and erythritol.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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University of Wisconsin, Madison
OTHER
Responsible Party
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Principal Investigators
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Kristina L Penniston, PhD, RDN, FAND
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison
Locations
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UW-Madison
Madison, Wisconsin, United States
Countries
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Other Identifiers
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A539800
Identifier Type: OTHER
Identifier Source: secondary_id
SMPH/UROLOGY/UROLOGY
Identifier Type: OTHER
Identifier Source: secondary_id
Protocol Version 9/9/2020
Identifier Type: OTHER
Identifier Source: secondary_id
2019-0621
Identifier Type: -
Identifier Source: org_study_id