Using sodium bicarbonate to change 24-hour urine measurements in people with low urine citrate or uric acid kidney stones
Impact of Sodium Bicarbonate on 24-hour Urine Parameters in Hypocitriuric and Uric Acid Stone Formers
PHASE1 · University of California, Irvine · NCT06335537
This will see if taking sodium bicarbonate instead of potassium citrate changes 24-hour urine measurements in adults with low urine citrate or uric acid kidney stones.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of California, Irvine (other) |
| Locations | 1 site (Orange, California) |
| Trial ID | NCT06335537 on ClinicalTrials.gov |
What this trial studies
This Phase 1 interventional study at the University of California, Irvine will switch eligible adults from potassium citrate (Urocit-K) to sodium bicarbonate and measure changes in 24-hour urine chemistry. Participants are adults with hypocitraturia (<320 mg/24 h) who form calcium oxalate or uric acid stones and are already on Urocit-K. The trial compares urinary citrate, urine pH, and other 24-hour urine parameters before and after the intervention. The protocol excludes people with reduced kidney function, diabetes, certain GI or metabolic disorders, pregnancy, or those taking thiazides or ACE inhibitors.
Who should consider this trial
Good fit: Adults aged 18–79 who form calcium oxalate or uric acid stones, have low urine citrate (<320 mg/24 h), are currently taking Urocit-K, and do not have excluded conditions like reduced kidney function, diabetes, pregnancy, or certain GI/metabolic disorders.
Not a fit: Patients with impaired kidney function (eGFR <60), active diabetes, pregnancy or breastfeeding, those on thiazides or ACE inhibitors, or people whose stones are not related to low citrate or acidic urine are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, sodium bicarbonate could offer a lower-cost alternative to potassium citrate to improve urine chemistry and lower stone recurrence risk.
How similar studies have performed: Potassium citrate is well established to raise urinary citrate, but substituting sodium bicarbonate as a lower-cost alternative has been less studied and remains relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * \> 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. Exclusion Criteria: * Male or female \<18 years old or \> 80 years old. * Currently taking thiazides or ACE inhibitor medications * Pregnant women. * Women who are breastfeeding or plan to breastfeed during study period * 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.
Where this trial is running
Orange, California
- University of California, Irvine Medical Center — Orange, California, United States (RECRUITING)
Study contacts
- Principal investigator: Sohrab N Ali, M.D — University of California, Irvine
- Study coordinator: Sohrab N Ali, M.D
- Email: sohrabna@hs.uci.edu
- Phone: 7145062352
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Uric Acid Stones, uric acid, hypocitraturia