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Assessment of Endogenous Oxalate Synthesis

Recruiting
18 - 75 years of age
Both
Phase N/A

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Overview

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.

Description

Urinary oxalate excretion is derived from both dietary sources and endogenous synthesis. This study will use low-oxalate controlled diet and intravenous infusion of the isotope tracer carbon 13 oxalate, timed with blood and urine collections, to determine the daily rate of endogenous oxalate synthesis in non-stone forming volunteers and in subjects with calcium oxalate kidney stones. A DXA scan will be used to assess body composition.

Eligibility

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

Study details

Healthy, Kidney Stone, Obesity

NCT05229952

University of Alabama at Birmingham

20 February 2024

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