Impact of Sodium Bicarbonate on 24-hour Urine Parameters in Hypocitriuric and Uric Acid Stone Formers

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

The incidence of kidney stone disease continues to rise globally. Although the treatment of kidney stone disease has dramatically improved in recent years, surgical management remains invasive and expensive. Patients who develop kidney stones are at high risk of recurrence during their lifetime; therefore, prevention of stones should be a primary focus. Low levels of citrate and acidic urine are risk factors for the formation of kidney stones such as calcium oxalate and uric acid, respectively. Calcium oxalate stones are the predominant stone composition in the United States, accounting for over 2/3rds of stones. Citrate is a key inhibitor of calcium oxalate crystal formation and thus increasing it in the urine of a calcium oxalate stone former is quite beneficial. Uric acid stones account for approximately 10 percent of all stone types. These stones form primarily due to an acidic urinary environment which is a prerequisite for crystal formation. Common medications for stone formers include potassium citrate which help to make the urine more alkaline. Although effective, these medications have side effects and may prove to be too expensive (upwards of $450/month). Consuming baking soda (sodium bicarbonate) may prove to be an inexpensive ($0.34/month) equally effective alternative with respect to increasing urinary citrate levels and alkalinizing the urine. Investigators hypothesize that twice a day oral baking soda in a liquid medium (e.g., water, orange juice, soda, etc.) can be an effective, and inexpensive alternative to urocit K with regard to alkalinizing the urine and raising urinary citrate levels.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• \> 18 years of age and \< 80 years of age,

• Hypocitriuric (\<320 mg/24 hours), Calcium Oxalate Stone or Uric Acid stone formers, currently on Urocit-K therapy as the standard of care.

Locations
United States
California
University of California, Irvine Medical Center
RECRUITING
Orange
Contact Information
Primary
Sohrab N Ali, M.D
sohrabna@hs.uci.edu
7145062352
Backup
Renai Yoon, B.S.
yoonrh@hs.uci.edu
7144568176
Time Frame
Start Date: 2025-05-01
Estimated Completion Date: 2026-07
Participants
Target number of participants: 100
Treatments
Experimental: Urocit-K, then Baking Soda
After being off Urocit-K for two weeks, participants will collect two 24-hour urine tests to document hypocitraturia or low urine pH for calcium oxalate or uric acid stone formers, respectively. Participants will take Urocit-K 30 mEq AM and 30 mEq PM for four-weeks. During the last two days of the four-week drug period, two 24-hour urine collections will be obtained, and the participants will enter another washout period of two weeks before switching over to Baking Soda dissolved in up to 250 mL of water ½ teaspoon (29.5 mEq) in AM and ½ Teaspoon (29.5 mEq) in PM for four weeks. During the last two days of this study arm, two 24-hour urine collections will be obtained. A basic metabolic panel blood test will be obtained at the end of the study arm.
Experimental: Baking Soda, then Urocit-K
After being off Urocit-K for two weeks, participants will collect two 24-hour urine tests to document hypocitraturia or low urine pH for calcium oxalate or uric acid stone formers, respectively. Participants will take Baking Soda dissolved in up to 250 mL of water ½ teaspoon (29.5 mEq) in AM and ½ Teaspoon (29.5 mEq) in PM for four weeks. During the last two days of the four-week drug period, two 24-hour urine collections will be obtained, and the participants will enter another washout period of two weeks before switching over to Urocit-K 30 mEq AM and 30 mEq PM for four weeks. During the last two days of this study arm, two 24-hour urine collections will be obtained. A basic metabolic panel blood test will be obtained at the end of the study arm.
Related Therapeutic Areas
Sponsors
Leads: University of California, Irvine

This content was sourced from clinicaltrials.gov

Similar Clinical Trials