Low-Oxalate Diet + Tracer Infusion for Kidney Stone Risk Assessment

Recruiting in Palo Alto (17 mi)

Overseen bySonia Fargue, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Alabama at Birmingham

No Placebo Group

Trial Summary

What is the purpose of this trial?This study aims to determine the daily rate of endogenous synthesis of oxalate using carbon 13 oxalate isotope tracer technique and a low-oxalate controlled diet.

Eligibility Criteria

This trial is for mentally competent adults with a BMI of 18.5-50 who either have had kidney stones within the last 3 years or are healthy subjects. Kidney stone formers should have a recent stone composed mostly of calcium oxalate, while healthy participants need normal blood and urine tests.

Inclusion Criteria

I can understand and make decisions about my health care.

I have had a kidney stone made mostly of calcium oxalate in the last 3 years.

I am in good health and my urine oxalate level is below 40 mg/day.

+2 more

Exclusion Criteria

Your urine or blood tests show unusual chemical levels.

I am younger than 18 or older than 75.

You did not collect all of your urine for the 24-hour period during screening.

+3 more

Participant Groups

The study is testing how much oxalate our bodies make naturally by using two methods: a special diet low in oxalate and an IV infusion of a labeled version of oxalate to trace its production in the body.

1Treatment groups

Experimental Treatment

Group I: Constant infusion of 13C2-oxalateExperimental Treatment2 Interventions

Subjects who have passed screening, will consume a low-oxalate, normal calcium controlled diet for 5 days total. On Days 3 and 4, subjects will collect two 24-hour urines. On Day 5, they will receive a carbon 13 oxalate infusion which will occur at a constant rate for 6 hours, in the fasted state, following a priming dose. Hourly urine and twice hourly blood samples will be collected during the 6 hours. Meals will be resumed at the end of the infusion and timed urine collections will take place at home until the next day. A DXA scan will be performed to assess body composition at another date.