Back to results

Assessment of Endogenous Oxalate Synthesis

Primary Purpose

Healthy, Kidney Stone, Obesity

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Low-oxalate controlled diet

Primed, continuous intravenous infusion of 13C2-oxalate

About this trial

This is an interventional basic science trial for Healthy focused on measuring Oxalate, Kidney stones, Urolithiasis, Nephrolithiasis, Urologic disease, Oxalate metabolism

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Mentally competent adults, able to read and comprehend the consent form
Body Mass Index (BMI) between 18.5 and 45 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 >45 kg/m2

Sites / Locations

University of Alabama at BirminghamRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Constant infusion of 13C2-oxalate

Arm Description

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.

Outcomes

Primary Outcome Measures

Endogenous Oxalate Synthesis Rate

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

Secondary Outcome Measures

Urinary Oxalate excretion

24-hr urinary oxalate excretion (mg/day) after equilibration on the low-oxalate controlled diet, measured by ion chromatography coupled with mass spectrometry.

Urinary creatinine excretion

24-hr urinary creatinine excretion (g/day) after equilibration on the low-oxalate controlled diet.

Full Information

NCT ID

NCT05229952

First Posted

January 27, 2022

Last Updated

February 20, 2023

Sponsor

University of Alabama at Birmingham

1. Study Identification

Unique Protocol Identification Number

NCT05229952

Brief Title

Assessment of Endogenous Oxalate Synthesis

Official Title

Assessment of Endogenous Oxalate Synthesis

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 10, 2022 (Actual)

Primary Completion Date

October 2029 (Anticipated)

Study Completion Date

October 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy, Kidney Stone, Obesity

Keywords

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

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Constant infusion of 13C2-oxalate

Arm Type

Experimental

Arm Description

Intervention Type

Dietary Supplement

Intervention Name(s)

Low-oxalate controlled diet

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Primed, continuous intravenous infusion of 13C2-oxalate

Intervention Description

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.

Primary Outcome Measure Information:

Title

Endogenous Oxalate Synthesis Rate

Description

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

Time Frame

day 5

Secondary Outcome Measure Information:

Title

Urinary Oxalate excretion

Description

24-hr urinary oxalate excretion (mg/day) after equilibration on the low-oxalate controlled diet, measured by ion chromatography coupled with mass spectrometry.

Time Frame

day 3-4

Title

Urinary creatinine excretion

Description

24-hr urinary creatinine excretion (g/day) after equilibration on the low-oxalate controlled diet.

Time Frame

day 3-4

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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) 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sonia Fargue, PhD

Phone

205-9756932

kidneystone@uabmc.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sonia Fargue, PhD

Organizational Affiliation

University of Alabama at Birmingham

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Alabama at Birmingham

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sonia Fargue, PhD

Phone

205-975-6932

kidneystone@uabmc.edu

First Name & Middle Initial & Last Name & Degree

Research Coordinator

Phone

205-9345712

kidneystone@uabmc.edu

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Assessment of Endogenous Oxalate Synthesis

We'll reach out to this number within 24 hrs