Back to resultsThe Interplay Between Oxalate, Immunity and Infection
Primary Purpose
Kidney Stone
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Low Oxalate Diet
High Oxalate Diet
Sponsored by
About this trial
This is an interventional basic science trial for Kidney Stone focused on measuring Oxalate
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Low Oxalate Diet Followed by High Oxalate Diet
High Oxalate Diet Followed by Low Oxalate Diet
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Urinary Oxalate
Twenty-four hour urinary oxalate will be reported as mg/day
Crystalluria
Twenty-four hour crystalluria will be reported as particles/ml
Monocyte Cellular Bioenergetics
Cellular bioenergetics will be reported as oxygen consumption rate
Monocyte Mitochondrial Complex Activity
Monocyte mitochondrial complex activity will be reported as oxygen consumption rate
Monocyte Transcriptomics
Monocyte transcriptomics will be reported as gene expression (mRNA levels)
Secondary Outcome Measures
Full Information
NCT ID
NCT04605055
First Posted
October 12, 2020
Last Updated
May 24, 2023
Sponsor
University of Alabama at Birmingham
1. Study Identification
Unique Protocol Identification Number
NCT04605055
Brief Title
The Interplay Between Oxalate, Immunity and Infection
Official Title
The Interplay Between Oxalate, Immunity and Infection
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
November 30, 2026 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Stone
Keywords
Oxalate
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Low Oxalate Diet Followed by High Oxalate Diet
Arm Type
Experimental
Arm Description
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.
Arm Title
High Oxalate Diet Followed by Low Oxalate Diet
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Low Oxalate Diet
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
High Oxalate Diet
Intervention Description
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.
Primary Outcome Measure Information:
Title
Urinary Oxalate
Description
Twenty-four hour urinary oxalate will be reported as mg/day
Time Frame
Change between Baseline and Diets at 4 days
Title
Crystalluria
Description
Twenty-four hour crystalluria will be reported as particles/ml
Time Frame
Change between Baseline and Diets at 4 days
Title
Monocyte Cellular Bioenergetics
Description
Cellular bioenergetics will be reported as oxygen consumption rate
Time Frame
Change between Baseline and Diets at 4 days
Title
Monocyte Mitochondrial Complex Activity
Description
Monocyte mitochondrial complex activity will be reported as oxygen consumption rate
Time Frame
Change between Baseline and Diets at 4 days
Title
Monocyte Transcriptomics
Description
Monocyte transcriptomics will be reported as gene expression (mRNA levels)
Time Frame
Change between Baseline and Diets at 4 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tanecia Mitchell, PhD
Phone
205-996-2292
Email
taneciamitchell@uabmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tanecia Mitchell, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
12. IPD Sharing Statement
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The Interplay Between Oxalate, Immunity and Infection
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