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Dietary Oxalate and Innate Immunity in Kidney Stone Disease

NCT04051346 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2026-06-26

Study results available
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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

Interventions

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. 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.

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. 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.

Sponsors & Collaborators

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

    collaborator NIH

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Tanecia Mitchell, PhD · University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-05
Primary Completion
2025-05-01
Completion
2025-05-01

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04051346 on ClinicalTrials.gov