Gut Oxalate Absorption in Calcium Oxalate Stone Disease

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
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 absorption of dietary oxalate, 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 and moderately high amounts of oxalate for 5 days at a time * ingest a soluble form of oxalate and sugar preparations to test gut permeability * collect urine, blood, stool and breath sample during the fixed diets and the soluble oxalate test

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

age 18-70 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

Design model

Parallel

Treatments tested in this trial

  • Low-oxalate diet

    Dietary supplement

    4 days of fixed eucaloric diet with low oxalate (\<60 mg/day), normal calcium content (600-1000 mg/day)

  • High-oxalate diet

    Dietary supplement

    4 days of fixed eucaloric diet with moderately high oxalate (250-300 mg/day), normal calcium content (600-1000 mg/day)

  • soluble oxalate gut absorption test

    Other intervention

    Oral ingestion of 13C2-oxalate and sucralose.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Idiopathic Calcium Oxalate Kidney Stone PatientsExperimental treatment 3 interventions
Group B: Healthy non-kidney stone forming individualsActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

Net Gastrointestinal absorption of food-bound oxalate

difference between 24-hour urinary oxalate excretion on the high oxalate diet and the low oxalate diet, normalized to the difference in dietary oxalate composition of the two diets (%)

Time frame
4 day

Secondary outcomes

1

Absorption of soluble 13C2-oxalate

Proportion of 13C2-oxalate recovered in urine to the amount orally ingested (%)

Time frame
1 day
2

Estimated endogenous oxalate synthesis (oxalate mg/day)

24-hour urinary oxalate excretion on the low oxalate diet (mg/day)

Time frame
2 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alabama at Birmingham

Lead sponsor

University of Texas Southwestern Medical Center

Collaborator

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

Collaborator