Dietary Oxalate and Innate Immunity in Kidney Stone Disease

NCT04051346 | Completed Results

• 2 other identifiers: IRB-300003865R03DK123542
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

This study will test whether oxalate stimulates urinary crystals and impacts the immune system in healthy subjects using two controlled diets (low and high oxalate).

Conditions

Kidney Stone

Keywords

dietary oxalate; diet therapy

Outcome Measures

Primary Outcomes (3)

• Urinary Oxalate Excretion

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

  Days 4 and 14

• Crystalluria

  Crystalluria will be reported as particles/ml.

  Day 4 and 14

• Number of Participants With Monocyte Cellular Energetics

  Cellular energetic oxygen consumption traces will be examined.

  Days 4 and 14

Secondary Outcomes (1)

• Number of Participants With Monocyte Transcriptomics

  Days 4 and 14

Study Arms (2)

Low Oxalate Diet

EXPERIMENTAL

Subjects will consume a low oxalate diet for four days, with blood and 24-hour urine collections occurring at baseline and post diet. A ten day wash out period will follow, during which the subject will consume a self-selected diet. Subjects will then consume the high oxalate diet for the final four days, with blood and 24-hour urine collections once again occurring at baseline and post diet.

Dietary Supplement: Low Oxalate Diet

High Oxalate Diet

EXPERIMENTAL

Subjects will consume a high oxalate diet for four days, with blood and 24-hour urine collections occurring at baseline and post diet. A ten day wash out period will follow, during which the subject will consume a self-selected diet. Subjects will then consume the low oxalate diet for the final four days, with blood and 24-hour urine collections once again occurring at baseline and post diet.

Dietary Supplement: High Oxalate Diet

Interventions

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, to exercise strenuously, or to consume food or drink that is not provided to them.

Low Oxalate Diet

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, to exercise strenuously, or to consume food or drink that is not provided to them.

High Oxalate Diet

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy subjects (men and women) between the ages of 18 and 60 years of age
• No calcium oxalate kidney stones or other medical conditions
• Normal comprehensive metabolic panel (CMP)
• Non tobacco users
• Not pregnant
• BMI between 20-30 kg/m2
• Willing to abstain from vigorous exercise and vitamins/supplements during the study
• Willing to consume only provided diets, accurately collect 24-hour urine samples, and have blood drawn

You may not qualify if:

• Inability to sign and read the informed consent
• Any medical, psychiatric, or social conditions that would prohibit participants from abiding by the study requirements
• Physician refusal
• Pregnant women
• Active medical problems
• History of kidney stones or any medical condition that could influence absorption or excretion of oxalate
• Tobacco users
• Taking medications or dietary supplements
• BMI \>30 or \<20

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Tanecia Mitchell
• Organization: UAB

taneciam@uab.edu

2059962292

Study Officials

• Tanecia Mitchell, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 1, 2019
• First Posted: August 9, 2019
• Study Start: March 5, 2021
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: June 26, 2026
• Results First Posted: June 26, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Present to 5 years
• Access Criteria: Must contact PI of the study

Locations

US (1)