Oxalate and Citrate
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of Chicago
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 18-70
History of at least one calcium-based kidney stone
Age 18-70
No history of kidney stone
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Kidney stones Normal controls Consuming a special drink (sodium oxalate) during an all day visit to the University of Chicago research clinic
Other interventionConsuming 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.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Kidney stone formersOther 1 intervention
Group B: Non-kidney stone formersOther 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
6 hours2
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.
Time frame
6 hours3
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.
Time frame
6 hoursSecondary outcomes
1
Difference in change in concentration of urine oxalate from baseline between kidney stone patients and controls.
We will compare change in urine citrate and fractional excretion of citrate by change in oxalate at each time period (0 to 2-hours, 4-hours, and 6-hours) between kidney stone patients and controls
Time frame
6 hours2
Difference in change in concentration of urine citrate from baseline between kidney stone patients and controls.
We will compare change in urine citrate and fractional excretion of citrate by change in oxalate at each time period (0 to 2-hours, 4-hours, and 6-hours) between kidney stone patients and controls
Time frame
6 hours3
Difference in change in fractional excretions of citrate and oxalate from baseline between kidney stone patients and controls.
We will compare change in urine citrate and fractional excretion of citrate by change in oxalate at each time period (0 to 2-hours, 4-hours, and 6-hours) between kidney stone patients and controls
Time frame
6 hoursSponsors and contacts
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Source ClinicalTrials.gov