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Low-Oxalate Diet for Kidney Stones

N/A

Recruiting

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

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

Must have

Non-obese stone formers: Age 18-70, BMI between 18.5-29.9 kg/m2, History of at least one calcium-based kidney stone

Obese stone formers: Age 18-70, Body mass index (BMI) >=30kg/m2, History of at least one calcium-based kidney stone, Pre-protocol urine oxalate above the lab normal range (50mg/day)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 days

Awards & highlights

Study Summary

This trial aims to learn more about how oxalate, a compound found in many foods, may affect a person's chances of forming kidney stones.

Who is the study for?

This trial is for adults aged 18-70 who have had bariatric surgery or are obese, with a history of calcium-based kidney stones and high urine oxalate levels. It's not for those with certain bowel surgeries, inflammatory bowel disease, or non-calcium based kidney stones.Check my eligibility

What is being tested?

Participants will follow a special low-oxalate diet at home and then eat meals provided by the University of Chicago research clinic. They'll also provide urine samples and consume a liquid containing oxalate during an all-day clinic visit to study its effects on kidney stone formation.See study design

What are the potential side effects?

There may be minimal side effects from the dietary changes; however, specific side effects are not detailed in this summary. Participants should report any unusual symptoms they experience during the trial.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am 18-70 years old, not obese, and have had at least one calcium kidney stone.

Select...

I am aged 18-70, have a BMI of 30 or more, have had at least one calcium-based kidney stone, and my urine oxalate level is high.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 days for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Change in 24-hour urine oxalate from baseline to after 5 days on low oxalate diet (2 days on participant managed, 3 days on clinical research center prepared diet of 50mg/day)

Change in urine 13C2-oxalate from pre-load baseline (time 0) to 2, 4-, 6-, and 24-hour time points

Change in urine sucralose from pre-load baseline (time 0) to 2, 4-, 6-, and 24-hour time points

+3 more

Secondary outcome measures

Compare change in urine oxalate levels from baseline to post-low oxalate diet between the three groups: lean kidney stone patients, obese kidney stone patients, and post- Roux-en-Y gastric bypass kidney stone patients

Trial Design

1Treatment groups

Experimental Treatment

Group I: Subjects who will follow low-oxalate diet followed by visit to research clinicExperimental Treatment1 Intervention

30 stone-forming participants will be recruited to this study.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor

1,004 Previous Clinical Trials

819,747 Total Patients Enrolled

4 Trials studying Kidney Stones

762 Patients Enrolled for Kidney Stones

University of Alabama at BirminghamOTHER

1,590 Previous Clinical Trials

2,281,324 Total Patients Enrolled

14 Trials studying Kidney Stones

805 Patients Enrolled for Kidney Stones

Media Library

Special low-oxalate diet followed by all-day visit to University of Chicago research clinic Clinical Trial Eligibility Overview. Trial Name: NCT05356000 — N/A

Kidney Stones Research Study Groups: Subjects who will follow low-oxalate diet followed by visit to research clinic

Kidney Stones Clinical Trial 2023: Special low-oxalate diet followed by all-day visit to University of Chicago research clinic Highlights & Side Effects. Trial Name: NCT05356000 — N/A

Special low-oxalate diet followed by all-day visit to University of Chicago research clinic 2023 Treatment Timeline for Medical Study. Trial Name: NCT05356000 — N/A

Frequently Asked Questions

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

Are there any opportunities presently available to join this clinical experiment?

"According to the information provided clinicaltrials.gov, patient recruitment for this study has concluded - though it was active between June 2nd and April 26th of 2022. Presently, there are 146 other trials actively recruiting candidates with similar criteria."

Answered by AI

Are individuals aged 55 and older eligible to participate in this trial?

"This study is accepting participants of legal age (18+) and those below the age of 70."

Answered by AI

Would I be eligible to join this medical research endeavor?

"Patients with kidney stones between 18 and 70 years old are eligible to enroll in this clinical trial, which is expected to recruit around 30 participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

GI Oxalate Absorption

2023. "GI Oxalate Absorption". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05356000.

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