RECRUITING

Endogenous Oxalate Synthesis in Idiopathic Calcium Oxalate Kidney Stone Disease

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Endogenous Oxalate Synthesis in Idiopathic Calcium Oxalate Kidney Stone Formers

Quick Facts

Study Start:2025-05-20
Study Completion:2031-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06989320

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * age 18-80 yrs
  2. * Body Mass Index \> 18.5 kg/m2
  3. * Normal fasting serum electrolytes on comprehensive metabolic profile
  4. * Willing to ingest fixed diets
  5. * 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.
  6. * 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%
  1. * Chronic Kidney Disease stage 4-5
  2. * Primary hyperoxaluria, Enteric (secondary) hyperoxaluria
  3. * Liver, bowel, endocrine or renal diseases (other than idiopathic Calcium Oxalate kidney stones) or any other condition that may influence the absorption, transport or urinary excretion of ions, which will compromise the interpretation of results, including: Cystic fibrosis, Celiac disease, Cystinuria, Uric acid stone former, Nephrotic syndrome, Sarcoidosis, Renal tubular acidosis, Primary hyperparathyroidism, Neurogenic bladder, Urinary diversion, Chronic diarrhea, Bariatric surgery, Inflammatory bowel disease
  4. * Pregnancy or breast-feeding
  5. * Incompatible dietary requirements with the study, food allergies or intolerance to any of the foods in study menus
  6. * Active malignancy or treatment for malignancy within 12 months prior to screening
  7. * Utilization of immunosuppressive medication
  8. * Uncontrolled hypertension or diabetes
  9. * Diabetes type 1

Contacts and Locations

Study Contact

Sonia Fargue, PhD
CONTACT
205-975-6932
sfargue@uabmc.edu

Principal Investigator

Sonia Fargue, PhD
PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham

Study Locations (Sites)

United States, Alabama University of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
University of Texas South Western Medical Center
Dallas, Texas, 75390
United States

Collaborators and Investigators

Sponsor: University of Alabama at Birmingham

  • Sonia Fargue, PhD, PRINCIPAL_INVESTIGATOR, University of Alabama at Birmingham

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-20
Study Completion Date2031-12-31

Study Record Updates

Study Start Date2025-05-20
Study Completion Date2031-12-31

Terms related to this study

Keywords Provided by Researchers

  • oxalate synthesis

Additional Relevant MeSH Terms

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