NCT05417568 Oxalate-Driven Host Responses in Kidney Stone Disease
| NCT ID | NCT05417568 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Alabama at Birmingham |
| Condition | Kidney Stones |
| Study Type | INTERVENTIONAL |
| Enrollment | 88 participants |
| Start Date | 2023-05-19 |
| Primary Completion | 2027-05-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 88 participants in total. It began in 2023-05-19 with a primary completion date of 2027-05-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion 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. Exclusion Criteria: * 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.
Contact & Investigator
Tanecia Mitchell, PhD
PRINCIPAL INVESTIGATOR
University of Alabama at Birmingham
Frequently Asked Questions
Who can join the NCT05417568 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Kidney Stones. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05417568 currently recruiting?
Yes, NCT05417568 is actively recruiting participants. Contact the research team at taneciamitchell@uabmc.edu for enrollment information.
Where is the NCT05417568 trial being conducted?
This trial is being conducted at Birmingham, United States.
Who is sponsoring the NCT05417568 clinical trial?
NCT05417568 is sponsored by University of Alabama at Birmingham. The principal investigator is Tanecia Mitchell, PhD at University of Alabama at Birmingham. The trial plans to enroll 88 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.