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Oxalate-Driven Host Responses in Kidney Stone Disease

University of Alabama at Birmingham · with National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NCT05417568

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–60 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
88
US sites recruiting
1
Study start
May 19, 2023
Record last updated
May 15, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Low Oxalate Diet; High Oxalate Diet

Conditions: Kidney Stones

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Recruiting US locations

  • University of Alabama at Birmingham

    Birmingham, AL 35294

    Site contact: Tanecia Mitchell, PhD · (205) 996-2292 · taneciamitchell@uabmc.edu

Study contacts (from the official record)

  • Tanecia Mitchell, PhD · (205) 996-2292 · taneciamitchell@uabmc.edu
Oxalate-Driven Host Responses in Kidney Stone Disease (NCT05417568) | Bored Studies