We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effectiveness of Urinary Alkalinizing Agents on Kidney Stone Risk

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04095975
Recruitment Status : Completed
First Posted : September 19, 2019
Last Update Posted : November 22, 2021
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

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.

Condition or disease Intervention/treatment Phase
Kidney Stone Dietary Supplement: Baking Soda Dietary Supplement: LithoLyte Phase 4

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 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of Prescription vs. Non-prescription Urinary Alkalinizing Agents on Kidney Stone Risk
Actual Study Start Date : August 28, 2019
Actual Primary Completion Date : June 24, 2021
Actual Study Completion Date : June 24, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Stones

Arm Intervention/treatment
Active Comparator: 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.
Dietary Supplement: Baking Soda
Standard baking soda that can be bought from stores.

Active Comparator: 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.
Dietary Supplement: LithoLyte
LithoLyte is considered a medical food and consists of: potassium citrate, magnesium citrate, sodium bicarbonate, and erythritol.




Primary Outcome Measures :
  1. Change in 24 hour urine citrate [ Time Frame: Pre and 24 hour post intervention (up to 90 days) ]

    Pre-to-post intervention change in 24-hour urine citrate will be measured

    Reference range of Urine Citrate:

    18 years and older: 320-1240 mg/d

    1 year and older: greater than or equal to 150 mg/g.


  2. Change in 24 hour urine pH [ Time Frame: Pre and 24 hour post intervention (up to 90 days) ]

    Pre-to-post intervention change in 24-hour urine pH will be measured

    Reference range of Urine pH:

    Age 0 days and up: 5.0-8.0



Secondary Outcome Measures :
  1. Post-intervention 24-hour urine calcium [ Time Frame: Enrollment and follow up visit (approximately 90 days) ]

    Urine calcium levels will be measured post intervention.

    Reference range of Urine Calcium:

    0-17 years: up to 6.0 mg/kg/24 hours 18 years and up: 100-300 mg/24 hours


  2. 24 hour urine calcium [ Time Frame: Enrollment and follow up visit (approximately 90 days) ]

    Reference range of urine calcium:

    0-12 years: 7-31 mg/d Male 13 years and older: 16-49 mg/d Female 13 years and older: 13-40 mg/d


  3. Post interventional 24 hour urine supersaturation indices for calcium oxalate [ Time Frame: Enrollment and follow up visit (approximately 90 days) ]

    Supersaturation means there are too many salts and not enough fluids in the urine. It's the driving force behind stone formation. Post interventional 24 hour urine supersaturation indices for calcium oxalate will be measured.

    Reference range:

    0-12 years: 7-31 mg/d Male 13 years and older: 16-49 mg/d Female 13 years and older: 13-40 mg/d


  4. Post interventional 24 hour urine supersaturation indices for calcium phosphatase [ Time Frame: Enrollment and follow up visit (approximately 90 days) ]

    Supersaturation means there are too many salts and not enough fluids in the urine. It's the driving force behind stone formation. Post interventional 24 hour urine supersaturation indices for calcium phosphatase will be measured.

    Reference range:

    Age 18 years and up: 0.4-1.3 g/24 hour


  5. Cost of Treatment as measured by USD spent on the interventional drug [ Time Frame: End of study (approximately 90 days) ]
    Cost of baking soda versus LithoLyte.

  6. Patient acceptability [ Time Frame: End of study (approximately 90 days) ]

    Wisconsin Stone-QOL: answers range from a scale of 1-5, or yes/no

    Study Questionnaire: free text responses, or no/yes/I am no longer taking it




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04095975


Locations
Layout table for location information
United States, Wisconsin
UW-Madison
Madison, Wisconsin, United States, 53726
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Layout table for investigator information
Principal Investigator: Kristina L Penniston, PhD, RDN, FAND University of Wisconsin, Madison
Layout table for additonal information
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT04095975    
Other Study ID Numbers: 2019-0621
A539800 ( Other Identifier: UW Madison )
SMPH/UROLOGY/UROLOGY ( Other Identifier: UW Madison )
Protocol Version 9/9/2020 ( Other Identifier: UW Madison )
First Posted: September 19, 2019    Key Record Dates
Last Update Posted: November 22, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Kidney Calculi
Nephrolithiasis
Calculi
Pathological Conditions, Anatomical
Kidney Diseases
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Urolithiasis
Urinary Calculi
Male Urogenital Diseases