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NCT Number: NCT06331546

Gut Oxalate Absorption in Calcium Oxalate Stone Disease

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

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

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About this study

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 mg daily calcium in both), and by the soluble 13C2-oxalate oral test in both Calcium Oxalate Kidney Stone patients and matched controls.

Phase 1. Screening and low-oxalate diet 24-hr urinary excretions. Between the University of Alabama at Birmingham (UAB) and the University of Texas Southwestern Medical Center (UTSW), the study will enroll 40 subjects with idiopathic Calcium Oxalate Kidney Stone (20 Males/20 Females) and 40 non-kidney stone forming controls (20 Males/20 Females). Participants in the two groups will be matched for age (within 10 yrs) and gender. Screening will include blood complete metabolic profile and two 24-hr urine specimens collected at home on self-choice diets and anthropometric measurements.

Participants will then ingest the controlled low-oxalate (<60 mg/d) diet for 5 consecutive days and collect two 24-hr urines after 2 days of dietary equilibration.

Phase 2. 13C2-Oxalate gut absorption tests. On Day 5, participants will arrive after an overnight fast in the research unit to undergo the 13C2-oxalate absorption test. After a 1-hour baseline urine collection, they will ingest an oral load containing 100 mg 13C2-oxalate and 1 g sucralose, dissolved in bottled water. For the next 9 hrs, blood and urine will be collected hourly, and breath as more time points. They will remain on the fixed diet for 24 hrs with a breakfast 2 hours after the load, lunch 6 hrs post-load, and dinner at home 12 hrs post-load. They will collect the remainder of their 24-hr urine at home and the totality of the stool eliminated during the first 24 hrs after the load using kits provided.

Phase 3. High-oxalate diet 24-hr urinary excretions. After a minimum of 1 week wash-out period, during which participants will eat freely, participants will consume the high oxalate (250-300 mg/day) diet for the next 4 days. Two 24-hr urine specimens will be collected after 2 days of equilibration and a fasting blood draw on the morning of Day 5.

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Oral ingestion of 13C2-oxalate and sucralose.

Primary outcomes

  1. Net Gastrointestinal absorption of food-bound oxalate

    Time frame: 4 day

    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 (%)

Secondary outcomes

  1. Absorption of soluble 13C2-oxalate

    Time frame: 1 day

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

  2. Estimated endogenous oxalate synthesis (oxalate mg/day)

    Time frame: 2 days

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

Study contacts

Contact information is provided by the study sponsor or research team.

Sonia Fargue, PhD

CONTACT

[email protected]

2059756932

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • University of Texas Southwestern Medical Center

Registry information

Official study title

Gastrointestinal Oxalate Absorption in Calcium Oxalate Stone Disease

Important dates

Study start
2024
Primary completion
2030
Study completion
2031
First posted
Mar 26, 2024
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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