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Dietary Supplement

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

N/A

Recruiting

Led By Sonia Fargue, PhD

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

For kidney stone formers: first time or recurrent CaOx stone former with stone event within the prior 3 years. Composition of most recent stone (if known) > 50% calcium oxalate, without uric acid component.

Mentally competent adults, able to read and comprehend the consent form

Must not have

Aged <18 or >75 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 3-4

Awards & highlights

No Placebo-Only Group

Summary

This trial will study how much oxalate the body produces each day, using a low-oxalate diet and measuring the amount of a radioactive tracer in the body.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort from the IV infusion, changes in bowel habits due to the low-oxalate diet, and possible reactions at the infusion site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I can understand and make decisions about my health care.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am younger than 18 or older than 75.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 3-4

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 3-4

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 3-4 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Endogenous Oxalate Synthesis Rate

Secondary study objectives

Urinary Oxalate excretion

Urinary creatinine excretion

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 4Eligibility criteria met