Gut Oxalate Absorption in Calcium Oxalate Stone Disease

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT06331546
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • Low-oxalate diet — DIETARY_SUPPLEMENT
    4 days of fixed eucaloric diet with low oxalate (\<60 mg/day), normal calcium content (600-1000 mg/day)
  • High-oxalate diet — DIETARY_SUPPLEMENT
    4 days of fixed eucaloric diet with moderately high oxalate (250-300 mg/day), normal calcium content (600-1000 mg/day)
  • soluble oxalate gut absorption test — OTHER
    Oral ingestion of 13C2-oxalate and sucralose.

Study Details

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

Key Dates

Start date
Apr 17, 2024
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 and High oxalate fixed diets. Soluble oxalate absorption test.
  • Active Comparator: Healthy non-kidney stone forming individuals
    Low and High oxalate fixed diets. Soluble oxalate absorption test.

Primary Outcome Measure

Net Gastrointestinal absorption of food-bound oxalate [ Time Frame: 4 day ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294
Sonia Fargue, PhD
[email protected]
205-9756932
Research Coordinator
[email protected]
205-9345712
Sonia Fargue, PhD (PRINCIPAL_INVESTIGATOR)
UTSWDallasTexas75390-

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By research site
University of Alabama at Birmingham· Birmingham, ALUTSW· Dallas, TX

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