Endogenous Oxalate Synthesis in Idiopathic Calcium Oxalate Kidney Stone Disease

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Alabama at Birmingham

About 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

Eligibility criteria

Qualifiers

age 18-80 yrs

Body Mass Index > 18.5 kg/m2

Normal fasting serum electrolytes on comprehensive metabolic profile

Willing to ingest fixed diets

Disqualifiers

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

Trial design

Treatments tested in this trial

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

Treatment groups

80 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Alabama at Birmingham

Lead sponsor

University of Texas, Southwestern Medical Center at Dallas

Collaborator

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

Collaborator