Endogenous Oxalate Synthesis in Idiopathic Calcium Oxalate Kidney Stone Formers

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: t
View:

• age 18-80 yrs

• Body Mass Index \> 18.5 kg/m2

• Normal fasting serum electrolytes on comprehensive metabolic profile

• Willing to ingest fixed diets

• Willing to stop supplements (vitamins including vitamin C, calcium (citrate or carbonate) and other minerals, herbal supplements, nutritional aids, probiotics) for 2 weeks before start and during study.

• For stone formers: first time or recurrent Calcium Oxalate stone former. Composition of most recent stone ≥ 50% calcium oxalate if available, uric acid component \<20%

Locations
United States
Alabama
United States, Alabama University of Alabama at Birmingham
RECRUITING
Birmingham
Texas
University of Texas South Western Medical Center
NOT_YET_RECRUITING
Dallas
Contact Information
Primary
Sonia Fargue, PhD
sfargue@uabmc.edu
205-975-6932
Time Frame
Start Date: 2025-05-27
Estimated Completion Date: 2031-12-31
Participants
Target number of participants: 80
Treatments
Experimental: Idiopathic Calcium Oxalate Kidney Stone Patients
Low oxalate fixed diets. oral glycolate and ascorbic acid administration
Active_comparator: Healthy non-kidney stone forming individuals
Low oxalate fixed diets. oral glycolate and ascorbic acid administration
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Texas, Southwestern Medical Center at Dallas
Leads: University of Alabama at Birmingham

This content was sourced from clinicaltrials.gov

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