Actively Recruiting

Phase 1
Age: 18Years - 80Years
All Genders
ID06335537

Impact of Sodium Bicarbonate Compared to Potassium Citrate on Urine in Calcium Oxalate and Uric Acid Stone Formers

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

100

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Kidney stone disease is becoming more common worldwide, with calcium oxalate stones being the most frequent type in the United States, followed by uric acid stones. This research aims to evaluate whether sodium bicarbonate, a low-cost alternative to potassium citrate, can effectively increase urine citrate levels and alkalinize urine in people who form these stones. The study is a randomized, phase 1 trial focusing on preventing recurrence of kidney stones by improving urine chemistry. Participants will be randomly assigned to one of two treatment sequences: either starting with potassium citrate (Urocit-K) for four weeks followed by a washout period and then sodium bicarbonate (baking soda) for four weeks, or vice versa. Potassium citrate is taken as 30 mEq tablets twice daily, while sodium bicarbonate is taken dissolved in water or another liquid as half a teaspoon (29.5 mEq) twice daily. Urine samples will be collected at specific intervals to measure changes during each treatment period. Participants will collect 24-hour urine samples before and after each treatment phase to assess urine pH and citrate levels. Blood tests will be performed to monitor kidney function. Researchers will measure changes in urinary pH and citrate as primary outcomes, along with calcium oxalate and uric acid supersaturation as secondary outcomes. The total study duration includes treatment periods, washouts, and sample collections over approximately 12 weeks, with ongoing safety monitoring throughout.

CONDITIONS

Brief 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 between 18 and 80 years
  • Diagnosed with calcium oxalate or uric acid kidney stones
  • Low urine citrate levels (hypocitraturia) or low urine pH
  • Currently taking potassium citrate (Urocit-K) as standard treatment
Not Eligible

You will not qualify if you...

  • Younger than 18 years or older than 80 years
  • Taking thiazide or ACE inhibitor medications
  • Pregnant women
  • Women who are breastfeeding or planning to breastfeed during the study
  • History of abnormal kidney function (eGFR <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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Approximately 12 weeks including washout periods

Participants will take either potassium citrate or sodium bicarbonate for four weeks, with urine collections during the last two days of each treatment period to assess urinary changes. After a two-week washout period, participants will switch to the other treatment for another four weeks, with similar urine collections at the end.

Multiple visits including baseline, end of each 4-week treatment, and after washout periods

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

R

Renai Yoon, B.S.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

Frequently Asked Questions

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Published Research Related To This Trial

The effect of sodium bicarbonate upon urinary citrate excretion in calcium stone formers.

Vivian Barbosa Pinheiro, Alessandra Calábria Baxmann, Hans-Göran Tiselius...

https://pubmed.ncbi.nlm.nih.gov/23602798