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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)

Must not have

Post-Roux-en-Y gastric bypass stone formers: History of colon resection (partial or complete), History of duodenal switch bowel surgery, History of ileal-jejunal bypass surgery, History of primarily uric acid, cysteine, or struvite stones

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 days

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

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

Select...

I have had gastric bypass and specific types of bowel surgery or stones.

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

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

Primary study objectives

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 study objectives

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