Clinical trial NCT04605055: The Interplay Between Oxalate, Immunity and Infection
Official title: The Interplay Between Oxalate, Immunity and Infection
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Kidney Stone
Keywords: Oxalate
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2020-10-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study consists of having subjects, those with calcium oxalate kidney stones as well as healthy controls, consume low and oxalate enriched diets to investigate the role of oxalate on crystalluria (the presence of crystals in urine), immunity and infection.


Eligibility criteria: Inclusion Criteria:

* Able to provide informed consent
* Body Mass Index (BMI) between 20-30 kg/m2
* Non tobacco users or not pregnant/breast feeding/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 appropriate ratio of creatinine (mg)/body weight (kg) for gender
* Healthy subjects: No history of calcium oxalate kidney stones (CaOx KS) or other medical conditions
* Patients with CaOx KS: Recent stone composition greater than 50% CaOx; no uric acid or struvite stone content must be present. Must be first time or recurrent CaOx stone former (last stone event within the past 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 University of Alabama Center for Clinical and Translational Science 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 kidney stone 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 anti-oxidant 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 to the study requirements
* BMI greater than 30 kg/m2 or less than 20 kg/m2
* Tobacco users or pregnant or breast feeding/nursing women
* Abnormal fasting blood comprehensive metabolic panel, complete blood count, C-reactive protein, and urinalysis. Inaccurate 24-hour urine collections.
* Healthy subjects: Taking medications or dietary supplements. History of kidney stones 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.
* Active disease including diabetes, gout, hypertension, primary hyperoxaluria, nephrotic syndrome, enteric hyperoxaluria, renal tubular acidosis, primary hyperparathyroidism, liver disease, autoimmune disorder, neurogenic bladder, urinary diversion, and bariatric surgery.
* Active malignancy or treatment for malignancy within 12 months prior to screening.

Primary outcomes:
measure: Urinary Oxalate
timeFrame: Change between Baseline and Diets at 4 days
measure: Crystalluria
timeFrame: Change between Baseline and Diets at 4 days
measure: Monocyte Cellular Bioenergetics
timeFrame: Change between Baseline and Diets at 4 days
measure: Monocyte Mitochondrial Complex Activity
timeFrame: Change between Baseline and Diets at 4 days
measure: Monocyte Transcriptomics
timeFrame: Change between Baseline and Diets at 4 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Alabama at Birmingham
name: Tanecia Mitchell, PhD
role: PRINCIPAL_INVESTIGATOR
References: