Understanding how dietary oxalate affects kidney stones and immunity
Oxalate-Driven Host Responses in Kidney Stone Disease
This study tests how different amounts of oxalate in food affect kidney stones and the immune system in both healthy people and those with kidney stones.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 88 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Locations | 1 site (Birmingham, Alabama) |
| Trial ID | NCT05417568 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of dietary oxalate on the formation of kidney stones and the immune response in both healthy individuals and those with calcium oxalate kidney stones. Participants will follow controlled low and high oxalate diets over a three-week period, during which they will provide blood and urine samples to assess changes in urinary crystals and immune activity. The study aims to clarify the relationship between oxalate consumption and kidney stone development, potentially leading to better dietary recommendations for prevention.
Who should consider this trial
Good fit: Ideal candidates include healthy adults aged 18-60 and individuals with a history of calcium oxalate kidney stones.
Not a fit: Patients with other types of kidney stones or those with significant medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into dietary modifications that may help prevent kidney stone formation.
How similar studies have performed: While the role of dietary oxalate in kidney stone formation has been explored, this specific approach of controlled dietary intervention is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Birmingham, Alabama
- University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
Study contacts
- Principal investigator: Tanecia Mitchell, PhD — University of Alabama at Birmingham
- Study coordinator: Tanecia Mitchell, PhD
- Email: taneciamitchell@uabmc.edu
- Phone: (205) 996-2292
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.