The Interplay Between Oxalate, Immunity and Infection

Kidney Stone Clinical Trial

Official title:

The Interplay Between Oxalate, Immunity and Infection

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04605055
• Other study ID #: IRB-300005965
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2024
• Est. completion date: June 30, 2027

Study information

• Verified date: June 2024
• Source: University of Alabama at Birmingham
• Contact: Tanecia Mitchell, PhD
• Phone: 205-996-2292
• Email: taneciamitchell[@]uabmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 88
• Est. completion date: June 30, 2027
• Est. primary completion date: April 30, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Kidney Calculi
• Kidney Stone

Intervention

Dietary Supplement:
• Low Oxalate Diet
Participants will consume a diet that is controlled in its daily contents of oxalate and calcium, and in its content of carbohydrate, fat, and protein.
• High Oxalate Diet
Participants will consume a diet that is controlled in its daily contents of oxalate and calcium, and in its content of carbohydrate, fat, and protein.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary Oxalate	Twenty-four hour urinary oxalate will be reported as mg/day	Change between Baseline and Diets at 4 days
Primary	Crystalluria	Twenty-four hour crystalluria will be reported as particles/ml	Change between Baseline and Diets at 4 days
Primary	Monocyte Cellular Bioenergetics	Cellular bioenergetics will be reported as oxygen consumption rate	Change between Baseline and Diets at 4 days
Primary	Monocyte Mitochondrial Complex Activity	Monocyte mitochondrial complex activity will be reported as oxygen consumption rate	Change between Baseline and Diets at 4 days
Primary	Monocyte Transcriptomics	Monocyte transcriptomics will be reported as gene expression (mRNA levels)	Change between Baseline and Diets at 4 days