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Dietary Supplement

Controlled Diet for Kidney Stone Prevention

N/A

Recruiting

Led By Dean Assimos, MD

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

Age 25-60 years

Be between 18 and 65 years old

Must not have

History of kidney stones

History of diabetes, hepatic disease, renal disease including Chronic Kidney Disease (CKD), bowel disease or other endocrine disorders

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through day 12

Awards & highlights

No Placebo-Only Group

Summary

This trial will help researchers understand how obesity affects the amount of oxalate excreted in urine, which could lead to new ways to prevent calcium oxalate stones from forming.

Who is the study for?

This trial is for adults aged 25-60 who are not obese (BMI <50) and have no history of kidney stones, diabetes, liver or renal diseases, bowel or other endocrine disorders. Pregnant women or those planning to become pregnant soon cannot participate.

What is being tested?

The study is testing the impact of a controlled low oxalate diet on non-obese and obese individuals without kidney stones. The goal is to understand how obesity affects the body's production of oxalate, which could lead to new treatments for preventing kidney stones.

What are the potential side effects?

Since this trial involves dietary changes rather than medication, side effects may include digestive discomfort due to diet adjustment. No significant medical side effects are expected from following a controlled diet.

Eligibility Criteria

Inclusion Criteria

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

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I am between 25 and 60 years old.

Exclusion Criteria

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

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I have had kidney stones in the past.

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I have a history of diabetes, liver, kidney, bowel diseases, or other hormone-related conditions.

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My liver enzymes are abnormal.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through day 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline through day 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through day 12 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Urinary oxalate excretion

Awards & Highlights

No Placebo-Only Group

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

Trial Design

6Treatment groups

Active Control

Group I: 20-24.9 BMIActive Control1 Intervention

Participants with a BMI that falls between 20 and 24.9 who will receive the controlled diet

Group II: 25-29.9 BMIActive Control1 Intervention

Participants with a BMI that falls between 25 and 29.9 who will receive the controlled diet

Group III: 30-34.9 BMIActive Control1 Intervention

Participants with a BMI that falls between 30 and 34.9 who will receive the controlled diet

Group IV: 35-39.9 BMIActive Control1 Intervention

Participants with a BMI that falls between 35 and 39.9 who will receive the controlled diet

Group V: 40-44.9 BMIActive Control1 Intervention

Participants with a BMI that falls between 40 and 44.9 who will receive the controlled diet

Group VI: 45-50 BMIActive Control1 Intervention

Participants with a BMI that falls between 45 and 50 who will receive the controlled diet.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor

1,655 Previous Clinical Trials

2,444,118 Total Patients Enrolled

13 Trials studying Kidney Stones

738 Patients Enrolled for Kidney Stones

Dean Assimos, MD5.05 ReviewsPrincipal Investigator - University of Alabama at Birmingham

University of Alabama at Birmingham

2 Previous Clinical Trials

62 Total Patients Enrolled

2 Trials studying Kidney Stones

62 Patients Enrolled for Kidney Stones

5Patient Review

Dr. Assimos and his team are outstanding. He removed a kidney stone for me in 2018 and was very patient in answering all my questions. The recent telehealth visits have been great as well — on time and efficient. Nurse Harvey is extremely responsive and helpful. Both Assimos and Harvey gave me their cell numbers for emergencies, which is rare these days. I highly recommend him and his team.