Oxalate and Citrate

NCT05334979 | Recruiting

• 1 other identifier: IRB21-1349
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Change in concentration of urine oxalate from baseline to 2-hours, 4-hours, and 6-hours after sodium oxalate consumption

  Concentration of urine oxalate will be measured or calculated at time points 0, 2-hours, 4-hours, and 6-hours after sodium oxalate consumption. We will compare change in urine citrate and fractional excretion of citrate by change in oxalate at each time period for all participants.

  6 hours

• Change in concentration of urine citrate from baseline to 2-hours, 4-hours, and 6-hours after sodium oxalate consumption.

  Concentration of urine citrate will be measured or calculated at time points 0, 2-hours, 4-hours, and 6-hours after sodium oxalate consumption. We will compare change in urine citrate and fractional excretion of citrate by change in oxalate at each time period for all participants.

  6 hours

• Change in fractional excretions of citrate and oxalate from baseline to 2-hours, 4-hours, and 6-hours after sodium oxalate consumption.

  Fractional excretion of citrate will be measured or calculated at time points 0, 2-hours, 4-hours, and 6-hours after sodium oxalate consumption. We will compare change in urine citrate and fractional excretion of citrate by change in oxalate at each time period for all participants.

  6 hours

Secondary Outcomes (3)

• Difference in change in concentration of urine oxalate from baseline between kidney stone patients and controls.

  6 hours

• Difference in change in concentration of urine citrate from baseline between kidney stone patients and controls.

  6 hours

• Difference in change in fractional excretions of citrate and oxalate from baseline between kidney stone patients and controls.

  6 hours

Study Arms (2)

Kidney stone formers

OTHER

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

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

Non-kidney stone formers

OTHER

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

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

Interventions

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

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.

Kidney stone formers; Non-kidney stone formers

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• hour urine oxalate within lab normal (\<50mg/day)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

RECRUITING

MeSH Terms

Conditions

Kidney Calculi

Interventions

Oxalic Acid

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Oxalates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: April 19, 2022
• Study Start: October 27, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 8, 2026

Record last verified: 2026-01

Locations

US (1)