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NCT06335537 · ClinicalTrials.gov registry record · Phase 1
Impact of Sodium Bicarbonate on 24-hour Urine Parameters in Hypocitriuric and Uric Acid Stone Formers
A Phase 1 study of Uric Acid Stones, sponsored by University of California, Irvine.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT06335537: Recruiting Phase 1 study of Uric Acid Stones, sponsored by University of California, Irvine.
NCT06335537 is a Phase 1 study of Uric Acid Stones that is actively recruiting participants, run by University of California, Irvine. The registered enrollment target is 100 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06335537, a Phase 1 study of Uric Acid Stones, is actively recruiting participants, sponsored by University of California, Irvine.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
The first primary outcome will be the change in urinary pH determined from the 24-hour urine analysis test conducted by Litholink®. Outcome variable: 24-hour urine pH greater than 6 (reference range from 5.8 to 6.2 pH).
Conditions Studied
Interventions
- DRUG Sodium bicarbonate
- DRUG Potassium citrate
Study Locations (1)
California
- University of California, Irvine Medical Center - Orange
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2025-05-01 |
| Est. Completion | 2026-07 |
| Phase | Phase 1 |
What NCT06335537 shows while recruiting
NCT06335537 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% higher).
The record links to 1 condition, with Uric Acid Stones appearing as the primary indexed condition, and to 2 interventions - of which Sodium bicarbonate is the first listed.
NCT06335537 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT06335537 about?
NCT06335537 is a clinical study titled "Impact of Sodium Bicarbonate on 24-hour Urine Parameters in Hypocitriuric and Uric Acid Stone Formers". 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; the...
What is the current status of trial NCT06335537?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 100 participants. The study started on 2025-05-01. Estimated completion is 2026-07.
What conditions does trial NCT06335537 study?
This clinical trial studies the following conditions: Uric Acid Stones.
What interventions are being tested in trial NCT06335537?
The interventions under investigation include: Sodium bicarbonate (DRUG), Potassium citrate (DRUG).
Who is sponsoring clinical trial NCT06335537?
This trial is sponsored by University of California, Irvine, which has 368 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06335537 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06335537's enrollment target sits among peer trials
100 547th of 2000 higher than 1,411 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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