Endogenous Oxalate Synthesis in Idiopathic Calcium Oxalate Kidney Stone Disease

Summary

The goal of this clinical trial study is to test if patients with idiopathic calcium oxalate kidney stones have an increased production of oxalate by the body, 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 amounts of oxalate for 5 days ingest a soluble form of glycolate and vitamin C collect urine, blood, stool during the dietary and oral dosing portions of the study and also collect breath sample during the oral glycolate test

Conditions

• Kidney Stones
• Kidney Calculi
• Urolithiasis
• Urolithiasis, Calcium Oxalate
• Nephrolithiasis
• Nephrolithiasis, Calcium Oxalate
• Oxalate Urolithiasis
• Healthy
• Healthy Volunteer

Interventions

DIETARY_SUPPLEMENT

Low-oxalate diet and glycolate dosing

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

DIETARY_SUPPLEMENT

Oral glycolate dosing

Oral 13C-glycolate dosing (0.5 mg/kg)

DIETARY_SUPPLEMENT

Oral 13C- ascorbic acid dosing

Oral 13C- ascorbic acid dosing (0.75 mg/kg)

Sponsors & Collaborators

• University of Texas, Southwestern Medical Center at Dallas

  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

80 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-05-27

Primary Completion

2030-12-31

Completion

2031-12-31

Countries

• United States

Study Locations