Gut Oxalate Absorption in Calcium Oxalate Stone Disease

Summary

The goal of this clinical trial study is to test if patients with idiopathic calcium oxalate kidney stones have an increased absorption of dietary oxalate, which would lead to increased urinary excretion of oxalate.

The study will recruit adult patients with a history of calcium oxalate kidney stones and healthy volunteers without kidney stones.

Participants will

* ingest fixed diets containing low and moderately high amounts of oxalate for 5 days at a time
* ingest a soluble form of oxalate and sugar preparations to test gut permeability
* collect urine, blood, stool and breath sample during the fixed diets and the soluble oxalate test

Conditions

• Kidney Stone
• Kidney Calculi
• Urolithiasis
• Urolithiasis, Calcium Oxalate
• Nephrolithiasis
• Nephrolithiasis, Calcium Oxalate
• Oxalate Urolithiasis
• Oxaluria
• Healthy

Interventions

DIETARY_SUPPLEMENT

Low-oxalate diet

4 days of fixed eucaloric diet with low oxalate (\<60 mg/day), normal calcium content (600-1000 mg/day)

DIETARY_SUPPLEMENT

High-oxalate diet

4 days of fixed eucaloric diet with moderately high oxalate (250-300 mg/day), normal calcium content (600-1000 mg/day)

OTHER

soluble oxalate gut absorption test

Oral ingestion of 13C2-oxalate and sucralose.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center

  collaborator OTHER

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

  collaborator NIH

• University of Alabama at Birmingham

  lead OTHER

Principal Investigators

• Sonia Fargue, PhD · University of Alabama at Birmingham

Study Design

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-04-17

Primary Completion

2030-12-31

Completion

2031-12-31

Countries

• United States

Study Locations