Health TrialsbyHealthPanel

Oxalate and Citrate in Humans - Response to Citrate

ConditionsKidney StoneHealthy
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 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age 18-70

History of at least one calcium-based kidney stone

Age 18-70

No history of kidney stone

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Kidney stone formers

    Other intervention

    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

    Other intervention

    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.

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: Kidney stone formersOther 1 intervention
Group B: Control cohortOther 1 intervention

Trial outcomes

Primary outcomes

1

Change in urine oxalate from baseline to 2-hours, 4-hours, and 6-hours after potassium citrate consumption.

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 hours
2

Change in urine citrate from baseline to 2-hours, 4-hours, and 6-hours after potassium citrate consumption.

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 hours
3

Change in fractional excretions of citrate and oxalate from baseline to 2-hours, 4-hours, and 6-hours after potassium citrate 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 hours

Secondary outcomes

1

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

We will compare change 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 hours
2

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

We will compare change 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 hours
3

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

We will compare change 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 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Chicago

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Source ClinicalTrials.gov
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