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Dietary Supplement

Oxalate-Controlled Diets for Kidney Stones

N/A

Recruiting

Led By Tanecia Mitchell, 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

Men and women between the ages of 18 and 60 years old

Patients with CaOx KS: Recent stone composition > 50% CaOx; no uric acid, struvite, or carbonate apatite stone content

Must not have

Active illness including COVID-19, flu, common cold, fever, diarrhea, urinary tract infections, or other infections 14 days before the study and throughout the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up days 3-4 and 13-14

Awards & highlights

No Placebo-Only Group

Summary

This trial is investigating how oxalate affects kidney stones and immunity. It will last for 3 weeks, during which participants will eat a controlled diet and provide blood and urine samples.

Who is the study for?

This trial is for adults aged 18-60 with a BMI of 20-30, not using tobacco or pregnant. It includes healthy individuals and those with calcium oxalate kidney stones who are willing to follow specific diets provided by the study and avoid vigorous exercise. Participants must be able to give informed consent, have normal blood tests, and collect accurate urine samples.

What is being tested?

The study aims to understand how dietary oxalate affects kidney stone formation and immune responses. For about three weeks, participants will consume either a low or high oxalate diet while providing blood and urine samples for analysis.

What are the potential side effects?

While the trial itself does not involve medication that typically has side effects, changes in diet can cause digestive discomfort such as bloating or constipation. The impact on each individual may vary based on their body's response to the dietary changes.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 60 years old.

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My recent kidney stone was mostly calcium oxalate, without uric acid, struvite, or carbonate apatite.

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I have no history of kidney stones or other significant health issues.

Exclusion Criteria

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

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I have not had any infections like COVID-19 or the flu in the last 14 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ days 3-4 and 13-14

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~days 3-4 and 13-14

This trial's timeline: 3 weeks for screening, Varies for treatment, and days 3-4 and 13-14 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 Nanocystalluria

Change in Urinary Oxalate

Monocyte Cellular Bioenergetics and Mitochondrial Function

+2 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Healthy ParticipantsExperimental Treatment2 Interventions

Healthy participants will randomly receive either high (250mg) or low (40mg) oxalate diet for for four days, a ten day "washout" period on a self-selected diet, and finally the opposite diet from the first for the last four days.

Group II: Calcium Oxalate Kidney StoneExperimental Treatment2 Interventions

Calcium oxalate kidney stone participants will randomly receive either high (250mg) or low (40mg) oxalate diet for for four days, a ten day "washout" period on a self-selected diet, and finally the opposite diet from the first for the last four days.

0 / 4Eligibility criteria met