N/A
N=23
Assessment of Endogenous Oxalate Synthesis
Healthy · Kidney Stone · Obesity
Bottom Line
View on ClinicalTrials.gov: NCT05229952 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: Endogenous Oxalate Synthesis Rate — 17 mg/day
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Low-oxalate controlled diet (Dietary_supplement); Primed, continuous intravenous infusion of 13C2-oxalate (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Sep 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Endogenous Oxalate Synthesis Rate |
17 | — |
| SECONDARY Urinary Oxalate Excretion |
20 | — |
| SECONDARY Urinary Creatinine Excretion |
1.6 | — |
Summary
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.
Eligibility Criteria
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)
- good health as judged from a medical history, reported medications, and a complete blood metabolic profile
- with or without history of calcium oxalate kidney stones
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 lower than 18 or greater than 75 years
- BMI lower than18.5 or greater than 50 kg/m2
Data sourced from ClinicalTrials.gov (NCT05229952). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.