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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 3-4

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Endogenous Oxalate Synthesis Rate

Secondary outcome measures

Urinary Oxalate excretion

Urinary creatinine excretion

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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor

1,590 Previous Clinical Trials

2,281,294 Total Patients Enrolled

14 Trials studying Kidney Stones

775 Patients Enrolled for Kidney Stones

Sonia Fargue, PhDPrincipal InvestigatorUniversity of Alabama at Birmingham

2 Previous Clinical Trials

120 Total Patients Enrolled

2 Trials studying Kidney Stones

120 Patients Enrolled for Kidney Stones

Media Library

Low-oxalate controlled diet (Dietary Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT05229952 — N/A

Kidney Stones Research Study Groups: Constant infusion of 13C2-oxalate

Kidney Stones Clinical Trial 2023: Low-oxalate controlled diet Highlights & Side Effects. Trial Name: NCT05229952 — N/A

Low-oxalate controlled diet (Dietary Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05229952 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research project allow for participants of a younger age bracket to partake?

"This clinical research project is open to applicants between the ages of 18 and 75. Separately, there are 258 trials that cater specifically to minors while 1036 aim at patients over 65 years old."

Answered by AI

Is this experiment recruiting participants at the moment?

"According to the information made available on clinicaltrials.gov, this medical study is currently recruiting participants as of February 21st 2022 (last update). This trial was first posted online a mere 11 days prior on February 10th."

Answered by AI

Is my participation in this research experiment permissible?

"In order to be eligible for this medical research, subjects must have a current diagnosis of kidney stones and fall within the age group between 18 and 75. A total of 60 participants are being admitted into the study."

Answered by AI

What is the upper limit of participants taking part in this experiment?

"Affirmative. According to clinicaltrials.gov, the trial which was first published on February 10th 2022 is still enrolling participants. Approximately 60 volunteers are needed from a single medical facility."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Assessment of Endogenous Oxalate Synthesis

Sonia Fargue 2022. "Assessment of Endogenous Oxalate Synthesis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05229952.

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