Kidney StonePhase 4NCT04095975
Effectiveness of Urinary Alkalinizing Agents on Kidney Stone Risk
A Phase 4 study testing Baking Soda and LithoLyte in people with Kidney Stone, run by University of Wisconsin, Madison at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Stone
- What is being tested?
- Baking Soda and LithoLyte
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2019to 24 Jun 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Prescription vs. Non-prescription Urinary Alkalinizing Agents on Kidney Stone Risk
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.
Read the 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.
- Conditions
- Kidney Stone
- Being tested
- Baking Soda, LithoLyte
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baking SodaDietary supplement
Standard baking soda that can be bought from stores.
LithoLyteDietary supplement
LithoLyte is considered a medical food and consists of: potassium citrate, magnesium citrate, sodium bicarbonate, and erythritol.
| Study group | Role | What they receive |
|---|---|---|
| Baking Soda | Active comparator | 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. Receives: Dietary Supplement: Baking Soda |
| LithoLyte | Active comparator | 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. Receives: Dietary Supplement: LithoLyte |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 24 hour urine citrate
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.
Measured: Pre and 24 hour post intervention (up to 90 days)
Change in 24 hour urine pH
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
Measured: Pre and 24 hour post intervention (up to 90 days)
Secondary outcomes (6)
Post-intervention 24-hour urine calcium
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
Measured: Enrollment and follow up visit (approximately 90 days)
24 hour urine calcium
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
Measured: Enrollment and follow up visit (approximately 90 days)
Post interventional 24 hour urine supersaturation indices for calcium oxalate
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
Measured: Enrollment and follow up visit (approximately 90 days)
Post interventional 24 hour urine supersaturation indices for calcium phosphatase
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
Measured: Enrollment and follow up visit (approximately 90 days)
Cost of Treatment as measured by USD spent on the interventional drug
Cost of baking soda versus LithoLyte.
Measured: End of study (approximately 90 days)
Patient acceptability
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
Measured: End of study (approximately 90 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start28 Aug 2019
- Primary completion24 Jun 2021
- Study completion24 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney StoneStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kristina L Penniston, PhD, RDN, FAND, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04095975
- Sponsor's protocol ID
- 2019-0621
- Other IDs
- A539800, SMPH/UROLOGY/UROLOGY, Protocol Version 9/9/2020
- Status last verified
- Nov 2021
- First submitted
- 17 Sep 2019
- Last updated
- 22 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Prescription vs. Non-prescription Urinary Alkalinizing Agents on Kidney Stone Risk
- ClinicalTrials.gov ID
- NCT04095975
- Acronym / sponsor ID
- 2019-0621
- Conditions
- Kidney Stone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 28 Aug 2019 (actual)
- Primary completion
- 24 Jun 2021 (actual)
- Study completion
- 24 Jun 2021 (actual)
- First posted
- 19 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baking Soda | Active comparator | Dietary Supplement: Baking SodaSubjects 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. |
| LithoLyte | Active comparator | Dietary Supplement: LithoLyteSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baking SodaStandard baking soda that can be bought from stores. | Dietary supplement | Baking Soda |
| LithoLyteLithoLyte is considered a medical food and consists of: potassium citrate, magnesium citrate, sodium bicarbonate, and erythritol. | Dietary supplement | LithoLyte |
Primary outcome
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.
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
6 secondary outcomes
Post-intervention 24-hour urine calcium
Time frame: Enrollment and follow up visit (approximately 90 days)
24 hour urine calcium
Time frame: Enrollment and follow up visit (approximately 90 days)
Post interventional 24 hour urine supersaturation indices for calcium oxalate
Time frame: Enrollment and follow up visit (approximately 90 days)
Post interventional 24 hour urine supersaturation indices for calcium phosphatase
Time frame: Enrollment and follow up visit (approximately 90 days)
Cost of Treatment as measured by USD spent on the interventional drug
Time frame: End of study (approximately 90 days)
Patient acceptability
Time frame: End of study (approximately 90 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristina L Penniston, PhD, RDN, FAND principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Baking Soda and LithoLyte in people with Kidney Stone, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 24 hour urine citrate (time frame: Pre and 24 hour post intervention (up to 90 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2021.