Effectiveness of Urinary Alkalinizing Agents on Kidney Stone Risk

NCT04095975 | Completed Phase 4

• 4 other identifiers: 2019-0621A539800SMPH/UROLOGY/UROLOGYProtocol Version 9/9/2020
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Stone

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  Pre and 24 hour post intervention (up to 90 days)

Secondary Outcomes (6)

• Post-intervention 24-hour urine calcium

  Enrollment and follow up visit (approximately 90 days)

• 24 hour urine calcium

  Enrollment and follow up visit (approximately 90 days)

• Post interventional 24 hour urine supersaturation indices for calcium oxalate

  Enrollment and follow up visit (approximately 90 days)

• Post interventional 24 hour urine supersaturation indices for calcium phosphatase

  Enrollment and follow up visit (approximately 90 days)

• Cost of Treatment as measured by USD spent on the interventional drug

  End of study (approximately 90 days)

Study Arms (2)

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.

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.

Dietary Supplement: LithoLyte

Interventions

Baking Soda DIETARY_SUPPLEMENT

Standard baking soda that can be bought from stores.

Baking Soda

LithoLyte DIETARY_SUPPLEMENT

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

LithoLyte

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

UW-Madison

Madison, Wisconsin, 53726, United States

Location

MeSH Terms

Conditions

Kidney Calculi

Interventions

Sodium Bicarbonate

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds

Study Officials

• Kristina L Penniston, PhD, RDN, FAND

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2019
• First Posted: September 19, 2019
• Study Start: August 28, 2019
• Primary Completion: June 24, 2021
• Study Completion: June 24, 2021
• Last Updated: November 22, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)