Actively Recruiting

Phase 1
Age: 18Years - 80Years
All Genders
NCT06335537

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

Led by University of California, Irvine · Updated on 2025-06-24

100

Participants Needed

1

Research Sites

60 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age greater than 18 years and less than 80 years
  • Hypocitriuric (less than 320 mg/24 hours) calcium oxalate or uric acid stone formers
  • Currently on Urocit-K (potassium citrate) therapy as standard care
Not Eligible

You will not qualify if you...

  • Younger than 18 years or older than 80 years
  • Currently taking thiazide or ACE inhibitor medications
  • Pregnant women
  • Women who are breastfeeding or plan to breastfeed during the study
  • History of abnormal kidney function (eGFR less than 60 mL/min/1.73 m2)
  • Active urinary tract infection
  • Diabetes
  • Cystinuria
  • Renal tubular acidosis
  • Inflammatory bowel disease
  • Chronic diarrhea
  • Primary hyperparathyroidism
  • Peptic ulcer disease

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of California, Irvine Medical Center

Orange, California, United States, 92868

Actively Recruiting

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Research Team

S

Sohrab N Ali, M.D

CONTACT

R

Renai Yoon, B.S.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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