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NCT Number: NCT05417568

Oxalate-Driven Host Responses in Kidney Stone Disease

This study is looking to understand the role of oxalate on kidney stone development and immunity. This study will enroll healthy participants and participants with calcium oxalate kidney stones (CaOx KS). Participants will be in this study for about 3 weeks, consume controlled diets, and provide blood and urine specimens.

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Key information

Conditions

Kidney Stones Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Calculi Kidney Diseases Male Urogenital Diseases Nephrolithiasis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Urinary Calculi Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location status: Recruiting

Location contact

Tanecia Mitchell, PhD

CONTACT

[email protected]

(205) 996-2292

Tanecia Mitchell, PhD

PRINCIPAL_INVESTIGATOR

About this study

The purpose of this longitudinal study is to examine the effects of dietary oxalate on nanocrystalluria and the immune system. Oxalate is a small molecule found in plants and plant-derived food. It has been shown that meals containing high amounts of oxalate can increase urinary oxalate excretion, which is a risk factor for calcium oxalate kidney stones (CaOx KS). Small increases in oxalate can stimulate urinary crystals to form which can elicit an immune response. This study consists of having healthy subjects and patients with CaOx KS consume both low and oxalate enriched diets to evaluate the effect of oxalate on urinary crystals and immune responses. Participants will receive a low or high oxalate diet for 4 days prior to having a wash-out period for 6 days. Participants will then crossover to the opposite oxalate diet for four more days.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low Oxalate Diet

Dietary Supplement

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. Participants will be asked not to take any dietary supplements, exercise strenuously, or consume food or drink that is not provided to them.

High Oxalate Diet

Dietary Supplement

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. Participants will be asked not to take any dietary supplements, exercise strenuously, or consume food or drink that is not provided to them.

Primary outcomes

  1. Change in Urinary Oxalate

    Time frame: Days 3-4 and 13-14

    Twenty-four hour urinary oxalate will be reported as mg/day.

  2. Change in Nanocystalluria

    Time frame: Days 3-4 and 13-14

    Nanocrystalluria will be reported as particles/ml.

  3. Monocyte Cellular Bioenergetics and Mitochondrial Function

    Time frame: Day 1

    Cellular bioenergetics and mitochondrial function will be reported as oxygen consumption rate (pmol/min/10,000 cells).

  4. Monocyte Cellular Bioenergetics and Mitochondrial Function

    Time frame: Day 4

    Cellular bioenergetics and mitochondrial function will be reported as oxygen consumption rate (pmol/min/10,000 cells).

  5. Monocyte Cellular Bioenergetics and Mitochondrial Function

    Time frame: Day 11

    Cellular bioenergetics and mitochondrial function will be reported as oxygen consumption rate (pmol/min/10,000 cells).

  6. Monocyte Cellular Bioenergetics and Mitochondrial Function

    Time frame: Day 14

    Cellular bioenergetics and mitochondrial function will be reported as oxygen consumption rate (pmol/min/10,000 cells).

  7. Monocyte Subtypes

    Time frame: Day 1

    Monocyte subtypes will be determined using flow cytometry (mean fluorescence intensity).

  8. Monocyte Subtypes

    Time frame: Day 4

    Monocyte subtypes will be determined using flow cytometry (mean fluorescence intensity).

  9. Monocyte Subtypes

    Time frame: Day 11

    Monocyte subtypes will be determined using flow cytometry (mean fluorescence intensity).

  10. Monocyte Subtypes

    Time frame: Day 14

    Monocyte subtypes will be determined using flow cytometry (mean fluorescence intensity).

  11. Monocyte Transcriptomics

    Time frame: Day 1

    Monocyte transcriptomics will be reported as gene expression (mRNA levels)

  12. Monocyte Transcriptomics

    Time frame: Day 4

    Monocyte transcriptomics will be reported as gene expression (mRNA levels)

  13. Monocyte Transcriptomics

    Time frame: Day 11

    Monocyte transcriptomics will be reported as gene expression (mRNA levels)

  14. Monocyte Transcriptomics

    Time frame: Day 14

    Monocyte transcriptomics will be reported as gene expression (mRNA levels)

Study contacts

Contact information is provided by the study sponsor or research team.

Tanecia Mitchell, PhD

CONTACT

[email protected]

(205) 996-2292

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jun 14, 2022
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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