RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-05-01
Study Completion:2026-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06335537

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * \> 18 years of age and \< 80 years of age,
  2. * Hypocitriuric (\<320 mg/24 hours), Calcium Oxalate Stone or Uric Acid stone formers, currently on Urocit-K therapy as the standard of care.
  1. * Male or female \<18 years old or \> 80 years old.
  2. * Currently taking thiazides or ACE inhibitor medications
  3. * Pregnant women.
  4. * Women who are breastfeeding or plan to breastfeed during study period
  5. * History of abnormal renal function (defined as 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.

Contacts and Locations

Study Contact

Sohrab N Ali, M.D
CONTACT
7145062352
sohrabna@hs.uci.edu
Renai Yoon, B.S.
CONTACT
7144568176
yoonrh@hs.uci.edu

Principal Investigator

Ralph V Clayman, MD
STUDY_DIRECTOR
University of California, Irvine
Sohrab N Ali, M.D
PRINCIPAL_INVESTIGATOR
University of California, Irvine

Study Locations (Sites)

University of California, Irvine Medical Center
Orange, California, 92868
United States

Collaborators and Investigators

Sponsor: University of California, Irvine

  • Ralph V Clayman, MD, STUDY_DIRECTOR, University of California, Irvine
  • Sohrab N Ali, M.D, PRINCIPAL_INVESTIGATOR, University of California, Irvine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-01
Study Completion Date2026-07

Study Record Updates

Study Start Date2025-05-01
Study Completion Date2026-07

Terms related to this study

Keywords Provided by Researchers

  • uric acid
  • hypocitraturia

Additional Relevant MeSH Terms

  • Uric Acid Stones