Recruiting

Potassium Citrate

Sponsor:

University of Chicago

Code:

NCT06944223

Conditions

Kidney Stone

Healthy

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Interventions

Kidney stone formers

Control cohort

Study Details

Brief summary:

This is a single-center study that aims to learn more about how two compounds found in food, oxalate and citrate, interact in the body and may influence a person's chances of forming kidney stones. The study will examine changes in urinary oxalate and citrate levels after participants consume potassium citrate.

Conditions

Kidney Stone

Healthy

Study ID

NCT06944223

Start date

Oct 1, 2025

Status verified date

Dec, 2025

Completion date

Jun 1, 2027

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Inclusion Criteria:

Stone formers (SF):

  • Age 18-70
  • History of at least one calcium-based kidney stone

Non-stone formers (NSF):

  • Age 18-70
  • No history of kidney stone
  • 24-hour urine oxalate within laboratory normal range (<50 mg/day)

Exclusion Criteria:

History of primarily uric acid, cysteine, or struvite stones

History of severe acid-base abnormality, very low (less than 100 mg/day) or very high (greater than 1500 mg/day) urine citrate

Any controls or stone former (SF) participants who cannot stop diuretic medication or alkali supplementation for the course of the study period

Chronic kidney disease (glomerular filtration rate <75 milliliters per minute per 1.73 square meters \[mL/min/1.73 m²\])

Non-stone formers (NSF) and stone formers (SF) with extreme levels of urine citrate will be excluded from this small initial study to reduce heterogeneity and remove focus from the extremes of citrate levels.

Study Design

Enrollment

24 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

other: Kidney stone formers

12 stone-forming subjects will be enrolled in this arm.

other: Control cohort

12 non-stone-forming subjects will be enrolled in this arm.

Interventions

Kidney stone formers

Consuming a special drink (potassium citrate) during an all-day visit to the University of Chicago research clinic

Subjects in both groups will be asked to partake in the same activities, as follows: The day before presenting to the research clinic, subjects will collect urine at home. Subjects will then come to the research clinic at the University of Chicago in Hyde Park, where they will spend most of the day. We will give them a special liquid that contains potassium citrate. After this, we will collect urine and blood samples throughout the day. While at the clinic, subjects will also receive a boxed lunch at the end of the visit.

Control cohort

Consuming a special drink (potassium citrate) during an all-day visit to the University of Chicago research clinic

Subjects in both groups will be asked to partake in the same activities, as follows: The day before presenting to the research clinic, subjects will collect urine at home. Subjects will then come to the research clinic at the University of Chicago in Hyde Park, where they will spend most of the day. We will give them a special liquid that contains potassium citrate. After this, we will collect urine and blood samples throughout the day. While at the clinic, subjects will also receive a boxed lunch at the end of the visit.

Primary outcome measure

  • Change in urine oxalate from baseline to 2-hours, 4-hours, and 6-hours after potassium citrate consumption. [ Time Frame: 6 hours ]
  • Change in urine citrate from baseline to 2-hours, 4-hours, and 6-hours after potassium citrate consumption. [ Time Frame: 6 hours ]
  • Change in fractional excretions of citrate and oxalate from baseline to 2-hours, 4-hours, and 6-hours after potassium citrate consumption. [ Time Frame: 6 hours ]

Central Contacts and Locations

Locations

University of Chicago Medical Center

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Megan Prochaska, MD

773-702-1000mprocha2@medicine.bsd.uchicago.edu

More Information

Sponsor

University of Chicago

Last update posted

Dec 16, 2025

Last verified

Dec, 2025

Keywords

  • kidney stone
  • kidney stones

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Chicago on 2025-12-16.