RECRUITING

Oxalate-Driven Host Responses in Kidney Stone Disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study is looking to understand the role of oxalate on kidney stone development and immunity. This study will enroll healthy participants and participants with calcium oxalate kidney stones (CaOx KS). Participants will be in this study for about 3 weeks, consume controlled diets, and provide blood and urine specimens.

Official Title

Oxalate-Driven Host Responses in Kidney Stone Disease

Quick Facts

Study Start:2023-05-19

Study Completion:2027-05-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05417568

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* Men and women between the ages of 18 and 60 years old. * Able to provide informed consent. * BMI between 20-30 kg/m2. * Non-tobacco users or not pregnant/breastfeeding/nursing. * Normal fasting blood comprehensive metabolic panel, complete blood count, C-reactive protein, and urinalysis. Must accurately collect two 24-hour urine collections within 20% of the appropriate ratio of creatinine (mg)/body weight (kg) for respective gender. * Healthy subjects: No history of CaOx KS or other medical conditions. * Patients with CaOx KS: Recent stone composition \> 50% CaOx; no uric acid, struvite, or carbonate apatite stone content. Must be first-time or recurrent CaOx stone former (last stone event ≤ 3 years). * Willing to not consume supplements (i.e. vitamins, Ca (citrate or carbonate) and other minerals, herbal supplements, nutritional aids, and probiotics) for 2 weeks before the study and during the study. * Willing to abstain from vigorous exercise during the study as this may compromise immune function. * Willing to consume diets provided only by the UAB CCTS Bionutrition Core. No food allergies or intolerance to any of the foods on the study menus. * Willing to accurately collect 24-hour urine samples, and to have blood drawn throughout the study. * If on medications for KS prevention (e.g. thiazides, citrate supplementation excluding calcium citrate), patients must be on a stable dose regimen for at least 8 weeks prior to and during screening, with no changes in dosing anticipated during the study. Patients should not take allopurinol for 2 weeks prior to screening since allopurinol has antioxidant properties.	* Failure to meet the inclusion criteria or physician refusal. * Inability to sign and read the informed consent. * Any medical, psychiatric, or social conditions that would prohibit participants from abiding by the study requirements. * BMI ˃30 kg/m2 and \<20 kg/m2 * Tobacco users or pregnant or breastfeeding/nursing women. * Abnormal fasting blood comprehensive metabolic panel, complete blood count, C-reactive protein, and urinalysis. Inaccurate 24-hour urine collections. * Healthy subjects: Currently taking or have recently taken medications within the last 3 months (i.e. antibiotics) or dietary supplements. History of KS or any medical condition that could influence absorption or excretion of oxalate. * 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.

Inclusion Criteria

Exclusion Criteria

* Men and women between the ages of 18 and 60 years old.
* Able to provide informed consent.
* BMI between 20-30 kg/m2.
* Non-tobacco users or not pregnant/breastfeeding/nursing.
* Normal fasting blood comprehensive metabolic panel, complete blood count, C-reactive protein, and urinalysis. Must accurately collect two 24-hour urine collections within 20% of the appropriate ratio of creatinine (mg)/body weight (kg) for respective gender.
* Healthy subjects: No history of CaOx KS or other medical conditions.
* Patients with CaOx KS: Recent stone composition \> 50% CaOx; no uric acid, struvite, or carbonate apatite stone content. Must be first-time or recurrent CaOx stone former (last stone event ≤ 3 years).
* Willing to not consume supplements (i.e. vitamins, Ca (citrate or carbonate) and other minerals, herbal supplements, nutritional aids, and probiotics) for 2 weeks before the study and during the study.
* Willing to abstain from vigorous exercise during the study as this may compromise immune function.
* Willing to consume diets provided only by the UAB CCTS Bionutrition Core. No food allergies or intolerance to any of the foods on the study menus.
* Willing to accurately collect 24-hour urine samples, and to have blood drawn throughout the study.
* If on medications for KS prevention (e.g. thiazides, citrate supplementation excluding calcium citrate), patients must be on a stable dose regimen for at least 8 weeks prior to and during screening, with no changes in dosing anticipated during the study. Patients should not take allopurinol for 2 weeks prior to screening since allopurinol has antioxidant properties.

* Failure to meet the inclusion criteria or physician refusal.
* Inability to sign and read the informed consent.
* Any medical, psychiatric, or social conditions that would prohibit participants from abiding by the study requirements.
* BMI ˃30 kg/m2 and \<20 kg/m2
* Tobacco users or pregnant or breastfeeding/nursing women.
* Abnormal fasting blood comprehensive metabolic panel, complete blood count, C-reactive protein, and urinalysis. Inaccurate 24-hour urine collections.
* Healthy subjects: Currently taking or have recently taken medications within the last 3 months (i.e. antibiotics) or dietary supplements. History of KS or any medical condition that could influence absorption or excretion of oxalate.
* 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.

Contacts and Locations

Study Contact

Tanecia Mitchell, PhD

CONTACT

(205) 996-2292

taneciamitchell@uabmc.edu

Principal Investigator

Tanecia Mitchell, PhD

PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Study Locations (Sites)

University of Alabama at Birmingham

Birmingham, Alabama, 35294

United States

Collaborators and Investigators

Sponsor: University of Alabama at Birmingham

Tanecia Mitchell, PhD, PRINCIPAL_INVESTIGATOR, University of Alabama at Birmingham

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-19

Study Completion Date2027-05-30

Study Record Updates

Study Start Date2023-05-19

Study Completion Date2027-05-30

Terms related to this study

Keywords Provided by Researchers

Kidney stones
Dietary oxalate

Additional Relevant MeSH Terms

Kidney Stones