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Dietary Supplement

Diet Impact on Kidney Stones in Obese Individuals

N/A

Waitlist Available

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

Permitted/willing to discontinue medications for kidney stone prevention, including thiazides, allopurinol, and febuxostat and citrate preparations, for 14 days before start and during the studies. They will be instructed to restart these medications at the conclusion of the study

First time or recurrent calcium oxalate stone former

Must not have

Primary hyperparathyroidism

Enteric hyperoxaluria

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through day 5

Awards & highlights

Summary

This trial will help researchers learn more about how different aspects of diet contribute to kidney stones in people of normal weight and in obese people.

Who is the study for?

This trial is for adults with normal (BMI ≥ 18.5 to < 25) or obese (BMI ≥ 30 to ≤ 45) who form calcium oxalate kidney stones, can consent, and follow a controlled diet without vigorous exercise. Excluded are those with diabetes, abnormal blood tests, certain kidney diseases, gastrointestinal disorders affecting oxalate transport, recent cancer treatment, pregnancy or breastfeeding women not using birth control.

What is being tested?

The study investigates how obesity affects the body's processing of oxalate in people prone to calcium oxalate kidney stones. Participants will follow a controlled diet and ingest Carbon-13 Oxalate and Sucralose to track their metabolism and urinary excretion patterns.

What are the potential side effects?

While the trial involves dietary changes rather than medication, potential side effects may include digestive discomfort due to new foods or supplements ingested during the study.

Eligibility Criteria

Inclusion Criteria

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

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I am willing to stop my kidney stone prevention meds for the study duration.

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I have had kidney stones made of calcium oxalate before.

Exclusion Criteria

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

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I have been diagnosed with primary hyperparathyroidism.

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I have high oxalate levels in my urine due to intestinal issues.

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I have a condition where my bladder doesn't empty properly due to nerve issues.

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I have been diagnosed with nephrotic syndrome.

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I have gout.

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My kidney function is reduced.

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I have been diagnosed with primary hyperoxaluria.

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I am currently taking medication that suppresses my immune system.

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I cannot use birth control during the study.

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I cannot or do not want to have an MRI.

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I have been diagnosed with renal tubular acidosis.

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I have a stomach or intestine condition that affects oxalate processing.

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I have been diagnosed with sarcoidosis.

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I have had weight loss surgery.

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I have long-term diarrhea.

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I have been diagnosed with cystinuria.

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My high blood pressure is not under control.

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I have cystic fibrosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through day 5

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline through day 5

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through day 5 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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Controlled Dietary StudyExperimental Treatment2 Interventions

Participants will consume the controlled diet for five days. After one day on the diet, subjects will provide three 24-hour urine collections. On the last dayof the diet, subjects will come in a fasted state to ingest a small amount of carbon-13 oxalate and sucralose, with hourly urine collections and blood samples being taken before and after the ingestion.

0 / 20Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor

1,621 Previous Clinical Trials

2,290,956 Total Patients Enrolled

13 Trials studying Kidney Stones

753 Patients Enrolled for Kidney Stones

Dean Assimos, MDPrincipal InvestigatorUniversity of Alabama at Birmingham

2 Previous Clinical Trials

80 Total Patients Enrolled

2 Trials studying Kidney Stones

80 Patients Enrolled for Kidney Stones

Media Library

Controlled Diet (Dietary Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT04333745 — N/A

Kidney Stones Research Study Groups: Controlled Dietary Study

Kidney Stones Clinical Trial 2023: Controlled Diet Highlights & Side Effects. Trial Name: NCT04333745 — N/A

Controlled Diet (Dietary Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04333745 — N/A

~1 spots leftby Dec 2024

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