Kidney Stones, Urolithiasis, Hypocitraturia, Nephrolithiasis
Conditions
Keywords
kidney stone, stone, calcium oxalate, calcium phosphate, potassium citrate, sodium bicarbonate, nephrolithiasis
Brief summary
Kidney stones affect 1 in every 11 people in the US each year. In patients with kidney stones who are prescribed medications for stone management, only 30.2% are adherent to a medication regime and even fewer, only 13.4 % are adherent with citrate medications. Prescription potassium citrate can be expensive for many patients, leading to non-compliance. Sodium bicarbonate is a potential medication alternative that is cheaper and can potentially alkalinize the urine and/or decrease the risk of future kidney stones. However, efficacy of alternatives to potassium potassium citrate are not well studied. This study seeks to evaluate sodium bicarbonate and assess its ability to alkalinize urine in a cohort of patients with kidney stones and compare this to prescription potassium citrate.
Detailed description
Kidney stones affect 1 in every 11 people in the United States each year. A recurrence rate of 50% at 10 years highlights the importance of metabolic management, which has shown to be effective at decreasing the recurrence of stone disease. Specialty guidelines have recommended that clinicians offer pharmacologic therapy to recurrent stone formers. However, among kidney stone patients prescribed medication for stone management, only 30.2% are adherent to a medication regimen and even fewer, only 13.4%, are adherent with citrate medications. Prescription potassium citrate (Kcit) can be cost-prohibitive for many patients, leading to non-compliance. The combination of the effectiveness of medication with the prohibitory cost of the prescriptions has led to the exploration of treatment alternatives which promise to alkalinize the urine and/or decrease the risk of future kidney stones, including sodium bicarbonate. However, the efficacy of these alternatives in comparison to Kcit are not well studied and often include other alkali equivalents. A short-term study with limited sample size suggests sodium bicarbonate to be a viable alternative to Kcit. Our goal is to evaluate sodium bicarbonate and assess its ability to alkalinize urine in a cohort of stone-forming patients and compare this to prescription Kcit.
Interventions
20 mEq Kcit twice a day (40 mEq daily
DRUGSodium Bicarbonate
650 mg sodium bicarbonate twice a day (35.2 mEq daily)
Sponsors
University of California, Los Angeles
University of California, Davis
Brigham and Women's Hospital
Landspitali University Hospital
University of California, San Diego
Centre hospitalier de l'Université de Montréal (CHUM)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
1. Patients with confirmed hypocitraturia identified and enrolled in study 2. Pre-study medical history and laboratory data will be recorded, and 24 hour urine will be obtained 3. Set diet will be followed x 48hrs while on first treatment (sodium bicarbonate or potassium citrate; order randomized for 50:50 chance) for at least 1 week 4. 24 Hour urine performed during 2nd day of set diet 5. 1 week washout 6. 1 week use of other medication (sodium bicarbonate or potassium citrate) 7. Set diet will be followed x 48hrs while on potassium citrate 8. 24 Hour urine performed during 2nd day of set diet 9. Change in citrate, pH, and ammonia will be recorded.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult \>18 years of age * History of nephrolithiasis * One 24h urine collections within one year of enrollment with hypocitraturia. * Patients currently utilizing or considering use of Kcit for stone prevention
Exclusion criteria
* Individuals with known metabolic disorders * Individuals with other known causes of nephrolithiasis * Anyone who, in the opinion of the PI, is unfit or unsuitable to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in 24-Hour Urinary Citrate Excretion from 24-Hour Urine Collection | 14 days | Change in 24-hour urinary citrate excretion measured from 24-hour urine collections obtained at baseline and after intervention. To determine if sodium bicarbonate is not significantly worse than potassium citrate by more than a clinically acceptable margin of -10 Unit: mg/day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Urine pH Measured from 24-Hour Urine Collection | 14 days | Change in urine pH measured from 24 hour urine collections obtained at baseline and after intervention units: pH |
| Change in 24 hour Urinary Ammonia Excretion from 24 Hour Urine Collection | 14 days | Change in 24 hour urinary ammonia excretion from 24 hour urine collections obtained at baseline and after intervention Unit: mmol/day |
Countries
Canada, Iceland, United States
Contacts
CONTACTJanelly B Jimenez
PRINCIPAL_INVESTIGATORKymora B Scotland, MD, PhD
University of California, Los Angeles
Outcome results
None listed