Endogenous Oxalate Synthesis in Idiopathic Calcium Oxalate Kidney Stone Disease

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT06989320
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • Low-oxalate diet and glycolate dosing — DIETARY_SUPPLEMENT
    Low-oxalate diet 4 days of fixed eucaloric diet with low oxalate (\<60 mg/day), normal calcium content (600-1000 mg/day)
  • Oral glycolate dosing — DIETARY_SUPPLEMENT
    Oral 13C-glycolate dosing (0.5 mg/kg)
  • Oral 13C- ascorbic acid dosing — DIETARY_SUPPLEMENT
    Oral 13C- ascorbic acid dosing (0.75 mg/kg)

Study Details

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

Key Dates

Start date
May 27, 2025
Status verified
May 2026
Primary completion
Dec 31, 2030
Completion
Dec 31, 2031

Study Design

Enrollment
80 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • 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

Primary Outcome Measure

Estimated endogenous oxalate synthesis (oxalate mg/day) [ Time Frame: 1 day ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
United States, Alabama University of Alabama at BirminghamBirminghamAlabama35294
Sonia Fargue, PhD
[email protected]
205-975-6932
Research Coordinator
[email protected]
205-934-5712
Sonia Fargue, PhD (PRINCIPAL_INVESTIGATOR)
University of Texas South Western Medical CenterDallasTexas75390
Naim Maalouf, MD
[email protected]
Research Coordinator
[email protected]
Naim Maalouf, MD (PRINCIPAL_INVESTIGATOR)

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By research site
United States, Alabama University of Alabama at Birmingham· Birmingham, ALUniversity of Texas South Western Medical Center· Dallas, TX

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