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Oxalate and Citrate Drink for Kidney Stones

N/A
Recruiting
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Non-stone formers (controls): Age 18-70, No history of kidney stone, 24-hour urine oxalate within lab normal (<50mg/day)
Stone formers: Age 18-70, History of at least one calcium-based kidney stone
Must not have
Any controls or stone-forming participants who cannot stop diuretic medication or alkali supplementation for the course of the study period
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 hours
Awards & highlights
No Placebo-Only Group

Summary

This trial is investigating how two compounds in food, oxalate and citrate, may affect kidney stone formation. Subjects will eat special diets for 5 days and then come in for testing at the University of Chicago.

Who is the study for?
This trial is for adults aged 18-70 who either have a history of calcium-based kidney stones or no history at all (controls). Participants should have normal urine oxalate levels. Those with a history of non-calcium stones, severe acid-base issues, or extreme urine citrate levels cannot join.
What is being tested?
The study investigates the effects of two dietary compounds, oxalate and citrate, on the likelihood of developing kidney stones. Participants will consume a special drink containing sodium oxalate during an all-day visit to the research clinic.
What are the potential side effects?
While not explicitly listed in the provided information, consuming sodium oxalate may potentially cause gastrointestinal discomfort or changes in mineral balance which could affect kidney function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18-70 years old, have never had a kidney stone, and my urine oxalate is normal.
Select...
I am between 18 and 70 years old and have had at least one calcium-based kidney stone.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I cannot stop taking my diuretic medication or alkali supplements for the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in concentration of urine citrate from baseline to 2-hours, 4-hours, and 6-hours after sodium oxalate consumption.
Change in concentration of urine oxalate from baseline to 2-hours, 4-hours, and 6-hours after sodium oxalate consumption
Change in fractional excretions of citrate and oxalate from baseline to 2-hours, 4-hours, and 6-hours after sodium oxalate consumption.
Secondary study objectives
Difference in change in concentration of urine citrate from baseline between kidney stone patients and controls.
Difference in change in concentration of urine oxalate from baseline between kidney stone patients and controls.
Difference in change in fractional excretions of citrate and oxalate from baseline between kidney stone patients and controls.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Non-kidney stone formersExperimental Treatment1 Intervention
25 non-stone-forming subjects will be enrolled in this arm.
Group II: Kidney stone formersExperimental Treatment1 Intervention
25 stone-forming subjects will be enrolled in this arm.

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor
1,062 Previous Clinical Trials
840,086 Total Patients Enrolled
6 Trials studying Kidney Stones
924 Patients Enrolled for Kidney Stones

Media Library

Non-kidney stone formers Clinical Trial Eligibility Overview. Trial Name: NCT05334979 — N/A
Kidney Stones Research Study Groups: Non-kidney stone formers, Kidney stone formers
Kidney Stones Clinical Trial 2023: Non-kidney stone formers Highlights & Side Effects. Trial Name: NCT05334979 — N/A
Non-kidney stone formers 2023 Treatment Timeline for Medical Study. Trial Name: NCT05334979 — N/A
~9 spots leftby Jul 2025
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