Assessment of Endogenous Oxalate Synthesis

NCT05229952 | Completed Results DMC

• 1 other identifier: IRB151020005-OXI
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy; Kidney Stone; Obesity

Keywords

Oxalate; Kidney stones; Urolithiasis; Nephrolithiasis; Urologic disease; Oxalate metabolism

Outcome Measures

Primary Outcomes (1)

• Endogenous Oxalate Synthesis Rate

  Daily oxalate synthesis rate (mg/day) determined by the 13c2-oxalate infusion method

  day 5

Secondary Outcomes (2)

• Urinary Oxalate Excretion

  day 3-4

• Urinary Creatinine Excretion

  day 3-4

Study Arms (1)

Constant infusion of 13C2-oxalate

EXPERIMENTAL

Subjects who have passed screening, will consume a low-oxalate, normal calcium controlled diet for 5 days total. On Days 3 and 4, subjects will collect two 24-hour urines. On Day 5, they will receive a carbon 13 oxalate infusion which will occur at a constant rate for 6 hours, in the fasted state, following a priming dose. Hourly urine and twice hourly blood samples will be collected during the 6 hours. Meals will be resumed at the end of the infusion and timed urine collections will take place at home until the next day. A DXA scan will be performed to assess body composition at another date.

Dietary Supplement: Low-oxalate controlled diet; Other: Primed, continuous intravenous infusion of 13C2-oxalate

Interventions

Low-oxalate controlled diet DIETARY_SUPPLEMENT

Participants will consume a diet that is controlled in its contents of protein, carbohydrates, fat, calcium, oxalate, vitamin C and sodium for 5 days. Participants will be asked not to take any dietary supplements, exercise strenuously, or consume food or drink that is not provided to them.

Constant infusion of 13C2-oxalate

Primed, continuous intravenous infusion of 13C2-oxalate OTHER

Participants will receive a continuous intravenous administration of carbon-13 oxalate, a naturally occurring form of oxalate, over the course of several hours until steady-state is achieved, using an IV catheter, while remaining fasting.

Constant infusion of 13C2-oxalate

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Related Publications (1)

• Fargue S, Wood KD, Crivelli JJ, Assimos DG, Oster RA, Knight J. Endogenous Oxalate Synthesis and Urinary Oxalate Excretion. J Am Soc Nephrol. 2023 Sep 1;34(9):1505-1507. doi: 10.1681/ASN.0000000000000176. Epub 2023 Jun 14. No abstract available.

  PMID: 37312251 RESULT

MeSH Terms

Conditions

Kidney Calculi; Obesity; Urolithiasis; Nephrolithiasis; Urologic Diseases

Condition Hierarchy (Ancestors)

Kidney Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms

Results Point of Contact

• Title: Dr Sonia Fargue
• Organization: University of Alabama at Birmingham

sfargue@uab.edu

2059756932

Study Officials

• Sonia Fargue, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 27, 2022
• First Posted: February 8, 2022
• Study Start: February 10, 2022
• Primary Completion: September 9, 2024
• Study Completion: September 9, 2024
• Last Updated: May 13, 2025
• Results First Posted: December 11, 2024

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)