The Interplay Between Oxalate, Immunity and Infection

Sponsor

University of Alabama at Birmingham (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04605055

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Stone	Dietary Supplement: Low Oxalate Diet Dietary Supplement: High Oxalate Diet	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

88 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

The Interplay Between Oxalate, Immunity and Infection

Anticipated Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Sep 30, 2026

Anticipated Study Completion Date :

Dec 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Low Oxalate Diet Followed by High Oxalate Diet Subjects will consume a low oxalate diet for four days, with blood collections on Days 1 and 4 and 24-hour urine collections on Days 3 and 4. A ten day wash out period will follow, during which participants will consume their normal diet. After the wash out period, subjects will consume a high oxalate diet for four days, with blood and 24-hour urine collections occurring again as described previously.	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. Dietary Supplement: 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.
Experimental: High Oxalate Diet Followed by Low Oxalate Diet Subjects will consume a high oxalate diet for four days, with blood collections on Days 1 and 4 and 24-hour urine collections on Days 3 and 4. A ten day wash out period will follow, during which participants will consume their normal diet. After the wash out period, subjects will consume a low oxalate diet for four days, with blood and 24-hour urine collections occurring again as described previously.	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. Dietary Supplement: 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.

Arm

Intervention/Treatment

Experimental: Low Oxalate Diet Followed by High Oxalate Diet

Subjects will consume a low oxalate diet for four days, with blood collections on Days 1 and 4 and 24-hour urine collections on Days 3 and 4. A ten day wash out period will follow, during which participants will consume their normal diet. After the wash out period, subjects will consume a high oxalate diet for four days, with blood and 24-hour urine collections occurring again as described previously.

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.

Dietary Supplement: 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.

Experimental: High Oxalate Diet Followed by Low Oxalate Diet

Subjects will consume a high oxalate diet for four days, with blood collections on Days 1 and 4 and 24-hour urine collections on Days 3 and 4. A ten day wash out period will follow, during which participants will consume their normal diet. After the wash out period, subjects will consume a low oxalate diet for four days, with blood and 24-hour urine collections occurring again as described previously.

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.

Dietary Supplement: 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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Alabama at Birmingham

Investigators

Principal Investigator: Tanecia Mitchell, PhD, University of Alabama at Birmingham

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tanecia Mitchell, PhD, Principal Investigator, University of Alabama at Birmingham

ClinicalTrials.gov Identifier:

NCT04605055

Other Study ID Numbers:

IRB-300005965

First Posted:

Oct 27, 2020

Last Update Posted:

Nov 8, 2021

Last Verified:

Nov 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Tanecia Mitchell, PhD, Principal Investigator, University of Alabama at Birmingham

Oxalate

Additional relevant MeSH terms:

Kidney Calculi

Study Results

No Results Posted as of Nov 8, 2021