Status:

RECRUITING

Gut Oxalate Absorption in Calcium Oxalate Stone Disease

Lead Sponsor:

University of Alabama at Birmingham

Collaborating Sponsors:

University of Texas Southwestern Medical Center

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

Conditions:

Kidney Stone

Kidney Calculi

Eligibility:

All Genders

18-70 years

Phase:

NA

Brief Summary

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 excret...

Detailed Description

In this study the investigators propose to measure the net gastrointestinal absorption of oxalate both by food-bound oxalate, using low- (\<60 mg/day) and high- (250-300 mg/day) oxalate diets (600-800...

Eligibility Criteria

Inclusion Criteria:

  • age 18-70 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%

Exclusion Criteria:

  • 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
  • Chronic NSAID use

Key Trial Info

Start Date :

April 17 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2031

Estimated Enrollment :

80 Patients enrolled

Trial Details

Trial ID

NCT06331546

Start Date

April 17 2024

End Date

December 31 2031

Last Update

May 13 2025

Active Locations (2)

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Page 1 of 1 (2 locations)

1

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35294

2

UTSW

Dallas, Texas, United States, 75390