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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

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Urinary oxalate excretion

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.

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,599 Previous Clinical Trials
2,287,880 Total Patients Enrolled
14 Trials studying Kidney Stones
795 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.

Media Library

Controlled Diet (Dietary Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT03704350 — N/A
Kidney Stones Research Study Groups: 20-24.9 BMI, 25-29.9 BMI, 30-34.9 BMI, 35-39.9 BMI, 40-44.9 BMI, 45-50 BMI
Kidney Stones Clinical Trial 2023: Controlled Diet Highlights & Side Effects. Trial Name: NCT03704350 — N/A
Controlled Diet (Dietary Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03704350 — N/A
~3 spots leftby Dec 2024
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