Oxalate Synthesis for Kidney Stones

Recruiting at 1 trial location

Overseen By Sonia Fargue, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Must not be taking: Immunosuppressants

Disqualifiers: Chronic kidney disease, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

80 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial study is to test if patients with idiopathic calcium oxalate kidney stones have an increased production of oxalate by the body, which would lead to increased urinary excretion of oxalate. The study will recruit adult patients with a history of calcium oxalate kidney stones and healthy volunteers without kidney stones. Participants will ingest fixed diets containing low amounts of oxalate for 5 days ingest a soluble form of glycolate and vitamin C collect urine, blood, stool during the dietary and oral dosing portions of the study and also collect breath sample during the oral glycolate test

Research Team

Sonia Fargue, PhD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

This trial is for adults who've had calcium oxalate kidney stones and healthy volunteers without a history of these stones. Participants will follow a special low-oxalate diet, take glycolate and vitamin C, and provide urine, blood, stool, and breath samples.

Inclusion Criteria

Body Mass Index > 18.5 kg/m2

Normal fasting serum electrolytes on comprehensive metabolic profile

Willing to ingest fixed diets

Exclusion Criteria

My kidney function is severely reduced.

Pregnancy or breast-feeding

Incompatible dietary requirements with the study, food allergies or intolerance to any of the foods in study menus

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Dietary Equilibration

Participants ingest a controlled low-oxalate diet for 5 consecutive days and collect two 24-hour urines after 2 days of dietary equilibration.

5 days

Daily monitoring (in-person and at home)

13C-glycolate Dosing Test

Participants undergo the oral 13C-glycolate dosing test with hourly blood and urine collections for 7 hours.

1 day

1 visit (in-person)

13C-ascorbic Acid Dosing Test

Participants ingest an oral dose of 13C-ascorbic acid and undergo hourly blood and urine collections for 7 hours the next day.

2 days

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Low-oxalate diet and glycolate dosing
• Oral 13C- ascorbic acid dosing
• Oral glycolate dosing

Trial Overview The study tests if people with idiopathic calcium oxalate kidney stones produce more body-made oxalate leading to higher levels in the urine. It involves controlled diets and dosing with oral glycolate and vitamin C to track changes.

Participant Groups

Group I: Idiopathic Calcium Oxalate Kidney Stone Patients Experimental Treatment 3 Interventions

Low oxalate fixed diets. oral glycolate and ascorbic acid administration

Group II: Healthy non-kidney stone forming individuals Active Control 3 Interventions

Low oxalate fixed diets. oral glycolate and ascorbic acid administration

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

University of Texas, Southwestern Medical Center at Dallas

Collaborator

Trials

18

Recruited

21,200+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+