Assessment of Endogenous Oxalate Synthesis
This study aims to determine the daily rate of endogenous synthesis of oxalate using carbon 13 oxalate isotope tracer technique and a low-oxalate controlled diet.
Conditions:
🦠 Healthy 🦠 Kidney Stone 🦠 Obesity
🗓️ Study Start (Actual) 10 February 2022
🗓️ Primary Completion (Estimated) October 2029
✅ Study Completion (Estimated) October 2030
👥 Enrollment (Estimated) 60
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Birmingham, Alabama, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Mentally competent adults, able to read and comprehend the consent form
    • * Body Mass Index (BMI) between 18.5 and 50 kg/m2
    • * Acceptable 24 hour urine collections (judged on screening)
    • * for non-stone formers, good health as judged from a medical history, reported medications, and a complete blood metabolic profile, baseline urinary oxalate excretion \< 40 mg/day
    • * for kidney stone formers: first time or recurrent CaOx stone former with stone event within the prior 3 years. Composition of most recent stone (if known) \> 50% calcium oxalate, without uric acid component.

    Exclusion Criteria:

    • * History of any hepatic, bowel, or endocrine disease or other condition that may influence the absorption, transport or urine excretion of ions
    • * Abnormal urine chemistries or blood metabolic profiles
    • * Poor 24 hour urine collections completed during screening, judged by 24 hour urine creatinine excretion (indicative of not collecting all urine in the 24 hour period)
    • * Pregnancy, intention to become pregnant in the near future, or lactation
    • * Aged \<18 or \>75 years
    • * BMI \<18.5 or \>50 kg/m2
Ages Eligible for Study: 18 Years to 75 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ 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

  • First Submitted 27 January 2022
  • First Submitted that Met QC Criteria 27 January 2022
  • First Posted 8 February 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 12 February 2024
  • Last Update Posted 14 February 2024
  • Last Verified February 2024