Trial Radar AI
Clinical Trial NCT06989320 for Kidney Stones, Kidney Calculi, Urolithiasis, Urolithiasis, Calcium Oxalate, Nephrolithiasis, Nephrolithiasis, Calcium Oxalate, Oxalate Urolithiasis, Healthy, Healthy Volunteer is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
One study matched filter criteria
Card View
Back to Search

Endogenous Oxalate Synthesis in Idiopathic Calcium Oxalate Kidney Stone Disease 80 Dietary

Recruiting
Clinical Trial NCT06989320 is an interventional study for Kidney Stones, Kidney Calculi, Urolithiasis, Urolithiasis, Calcium Oxalate, Nephrolithiasis, Nephrolithiasis, Calcium Oxalate, Oxalate Urolithiasis, Healthy, Healthy Volunteer that is recruiting. It started on May 27, 2025 with plans to enroll 80 participants. Led by University of Alabama at Birmingham, it is expected to complete by December 31, 2031. The latest data from ClinicalTrials.gov was last updated on May 31, 2025.
Brief Summary
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 ox...

Show More
Detailed Description
In this study the investigators propose to measure the production of oxalate by the body (endogenous oxalate synthesis), after equilibration on a low oxalate diet (<60 mg oxalate/day, 600-800 mg calcium/day) and estimate the importance of vitamin C and glycolate metabolism to oxalate production in both Calcium Oxalate Kidney Stone patients and matched controls by oral dosings of those two substances.

Phase 1. Scree...

Show More
Official Title

Endogenous Oxalate Synthesis in Idiopathic Calcium Oxalate Kidney Stone Formers

Conditions
Kidney StonesKidney CalculiUrolithiasisUrolithiasis, Calcium OxalateNephrolithiasisNephrolithiasis, Calcium OxalateOxalate UrolithiasisHealthyHealthy Volunteer
Other Study IDs
NCT ID Number
NCT06989320
Start Date (Actual)
2025-05-27
Last Update Posted
2025-05-31
Completion Date (Estimated)
2031-12-31
Enrollment (Estimated)
80
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
oxalate synthesis
Primary Purpose
Basic Science
Design Allocation
Non-Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalIdiopathic Calcium Oxalate Kidney Stone Patients
Low oxalate fixed diets. oral glycolate and ascorbic acid administration
Low-oxalate diet and glycolate dosing
Low-oxalate diet 4 days of fixed eucaloric diet with low oxalate (\<60 mg/day), normal calcium content (600-1000 mg/day)
Oral glycolate dosing
Oral 13C-glycolate dosing (0.5 mg/kg)
Oral 13C- ascorbic acid dosing
Oral 13C- ascorbic acid dosing (0.75 mg/kg)
Active ComparatorHealthy non-kidney stone forming individuals
Low oxalate fixed diets. oral glycolate and ascorbic acid administration
Low-oxalate diet and glycolate dosing
Low-oxalate diet 4 days of fixed eucaloric diet with low oxalate (\<60 mg/day), normal calcium content (600-1000 mg/day)
Oral glycolate dosing
Oral 13C-glycolate dosing (0.5 mg/kg)
Oral 13C- ascorbic acid dosing
Oral 13C- ascorbic acid dosing (0.75 mg/kg)
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Estimated endogenous oxalate synthesis (oxalate mg/day)
Basal rate of endogenous oxalate synthesis estimated by repeat fasted hourly urine collections (mg/day)
1 day
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
24-hour urinary oxalate excretion on low oxalate diet
mean 24-hour urinary oxalate excretion on the low oxalate diet (mg/day)
2 days
contribution of ascorbic acid breakdown to urinary oxalate excretion
contribution of ascorbic acid breakdown to oxalate synthesis (%)
2 days
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
  • age 18-80 yrs
  • Body Mass Index > 18.5 kg/m2
  • Normal fasting serum electrolytes on comprehensive metabolic profile
  • Willing to ingest fixed diets
  • Willing to stop supplements (vitamins including vitamin C, calcium (citrate or carbonate) and other minerals, herbal supplements, nutritional aids, probiotics) for 2 weeks before start and during study.
  • For stone formers: first time or recurrent Calcium Oxalate stone former. Composition of most recent stone ≥ 50% calcium oxalate if available, uric acid component <20%

  • Chronic Kidney Disease stage 4-5
  • Primary hyperoxaluria, Enteric (secondary) hyperoxaluria
  • Liver, bowel, endocrine or renal diseases (other than idiopathic Calcium Oxalate kidney stones) or any other condition that may influence the absorption, transport or urinary excretion of ions, which will compromise the interpretation of results, including: Cystic fibrosis, Celiac disease, Cystinuria, Uric acid stone former, Nephrotic syndrome, Sarcoidosis, Renal tubular acidosis, Primary hyperparathyroidism, Neurogenic bladder, Urinary diversion, Chronic diarrhea, Bariatric surgery, Inflammatory bowel disease
  • Pregnancy or breast-feeding
  • Incompatible dietary requirements with the study, food allergies or intolerance to any of the foods in study menus
  • Active malignancy or treatment for malignancy within 12 months prior to screening
  • Utilization of immunosuppressive medication
  • Uncontrolled hypertension or diabetes
  • Diabetes type 1
University of Alabama at Birmingham logoUniversity of Alabama at Birmingham478 active studies to explore
  • University of Texas, Southwestern Medical Center at Dallas logoUniversity of Texas, Southwestern Medical Center at Dallas284 active studies to explore
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) logoNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study Responsible Party
Sonia Fargue, Principal Investigator, Associate professor, University of Alabama at Birmingham
Study Central Contact
Contact: Sonia Fargue, PhD, 205-975-6932, [email protected]
2 Study Locations in 1 Countries

Alabama

United States, Alabama University of Alabama at Birmingham, Birmingham, Alabama, 35294, United States
Sonia Fargue, PhD, Contact, 205-975-6932, [email protected]
Research Coordinator, Contact, 205-934-5712, [email protected]
Sonia Fargue, PhD, Principal Investigator
Recruiting

Texas

University of Texas South Western Medical Center, Dallas, Texas, 75390, United States
Naim Maalouf, MD, Contact, [email protected]
Research Coordinator, Contact, [email protected]
Naim Maalouf, MD, Principal Investigator
Not yet recruiting