Understanding how dietary oxalate affects kidney stones and immunity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Modified Mini-PCNL vs Standard PCNL for Complex Kidney Stones

  This study tests whether a smaller 20 Fr access in modified mini-PCNL can match the stone-clearing success of the standard 24 Fr PCNL in adults with complex kidney stones.

  Recruiting The First Affiliated Hospital of Guangzhou Medical University · Guangzhou, Guangdong · NCT07697677

• Aspirating vs non-aspirating ureteral access sheath in RIRS for kidney stones

  This trial tests whether using an aspirating ureteral access sheath during retrograde intrarenal surgery improves stone clearance and reduces complications compared with a non-aspirating sheath in adults with small kidney stones.

  Recruiting Hitit University · Çorum, Çorum · NCT07568990

• Suction to collapse the kidney's collecting system after RIRS (retrograde intrarenal surgery)

  This trial will test whether actively suctioning the kidney's collecting system at the end of RIRS reduces early postoperative pain and infections for adults having kidney stone removal.

  Recruiting Kangdong Sacred Heart Hospital · Gandong-gu, Outside U.S./Canada · NCT07535281

• Compare two suction ureteroscope devices for kidney stones (FANS vs CVAC)

  This study tests whether two new suction-enabled ureteroscopes (FANS and CVAC) lead to better stone clearance for adults with small to medium kidney stones compared to each other.

  Recruiting Ohio State University · Columbus, Ohio · NCT07514351

• Negative-pressure suction during flexible ureteroscopy to reduce fluid absorption and infections

  This test will see if using a negative-pressure suction sheath during retrograde intrarenal surgery for adults with kidney stones reduces how much irrigation fluid their bodies absorb and lowers the risk of postoperative infections.

  Recruiting Lanzhou University Second Hospital · Lanzhou, Gansu · NCT07492147

• Outcomes and costs with the HugeMed 6.3 Fr flexible ureteroscope

  This trial will test whether the HugeMed 6.3 Fr flexible ureteroscope gives similar stone-free results while lowering costs compared with traditional flexible ureteroscopes in adults having RIRS for stones up to 2.5 cm.

  Recruiting University of Kansas Medical Center · Kansas City, Kansas · NCT07296835

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.