Recruiting

Oxalate & Citrate

Sponsor:

University of Chicago

Code:

NCT05334979

Conditions

Kidney Stone

Normal Controls

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Interventions

Kidney stones Normal controls Consuming a special drink (sodium oxalate) during an all day visit to the University of Chicago research clinic

Study Details

Brief summary:

This is a single-center study that aims to earn more about how two different compounds found in food, oxalate and citrate, may affect a person's chances of forming kidney stones.

Conditions

Kidney Stone

Normal Controls

Study ID

NCT05334979

Start date

Oct 27, 2022

Status verified date

Jan, 2026

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Inclusion Criteria:

Stone formers:

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

Non-stone formers (controls):

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

Exclusion Criteria:

  • History of primarily uric acid, cysteine, or struvite stones.
  • History of severe acid-base abnormality, very low (less than 100mg/day) or very high (greater than 1500mg/day) urine citrate.
  • Any controls or stone-forming participants who cannot stop diuretic medication or alkali supplementation for the course of the study period.
  • Non-stone formers and stone-formers 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

50 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

other: Kidney stone formers

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

other: Non-kidney stone formers

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

Interventions

Kidney stones Normal controls Consuming a special drink (sodium oxalate) during an all day visit to the University of Chicago research clinic

Consuming a special drink (sodium oxalate) during an all day visit to the University of Chicago research clinic

Subjects in both arms 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 will come in 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 oxalate, and they will receive a specially prepared breakfast that is low in oxalate and citrate. After this, we will collect urine and blood throughout the day. While at the clinic, subjects will also receive specially prepared snacks.

Primary outcome measure

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

Principal Investigator:

Megan Prochaska, MD

More Information

Sponsor

University of Chicago

Last update posted

Jan 8, 2026

Last verified

Jan, 2026

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 2026-01-08.