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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up days 3-4 and 13-14

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Nanocystalluria

Change in Urinary Oxalate

Monocyte Cellular Bioenergetics and Mitochondrial Function

+2 more

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 / 3Eligibility criteria met

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Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor

1,590 Previous Clinical Trials

2,281,394 Total Patients Enrolled

14 Trials studying Kidney Stones

747 Patients Enrolled for Kidney Stones

National Institutes of Health (NIH)NIH

2,701 Previous Clinical Trials

7,506,788 Total Patients Enrolled

2 Trials studying Kidney Stones

60 Patients Enrolled for Kidney Stones

Tanecia Mitchell, PhDPrincipal InvestigatorUniversity of Alabama at Birmingham

3 Previous Clinical Trials

190 Total Patients Enrolled

3 Trials studying Kidney Stones

190 Patients Enrolled for Kidney Stones

Media Library

High Oxalate Diet (Dietary Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT05417568 — N/A

Kidney Stones Research Study Groups: Calcium Oxalate Kidney Stone, Healthy Participants

Kidney Stones Clinical Trial 2023: High Oxalate Diet Highlights & Side Effects. Trial Name: NCT05417568 — N/A

High Oxalate Diet (Dietary Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05417568 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Have recruitments for this trial started yet?

"Evidenced by clinicialtrials.gov, this medical investigation is actively seeking participants. The study was posted on December 1st 2022 and has been most recently updated in October 4th 2022."

Answered by AI

What is the enrollment rate for this clinical experiment?

"Affirmative, clinicaltrials.gov records demonstrate that the trial is actively recruiting patients since its inaugural posting on December 1st 2022 up until recently when it was modified on October 4th 2022. This study requires 88 participants from a single site."

Answered by AI

Is the age limit for participants in this trial restricted to adults only?

"The eligibility requirements for this clinical trial specify that enrollees must be between 18 and 60 years old. Additionally, there are 10 trials open to minors and 98 studies available to the elderly population."

Answered by AI