Kidney StoneNCT04333745
Influence of Obesity on Oxalate Metabolism and Handling in Calcium Oxalate Stone Formers
A study testing Carbon-13 Oxalate and Sucralose Ingestion in people with Kidney Stone, run by University of Alabama at Birmingham at 2 sites in United States.
Trial summary
The primary goals of this study are to determine the contribution of dietary oxalate absorption, renal oxalate handling, and endogenous oxalate synthesis to urinary oxalate excretion in normal Body Mass Index (BMI) and obese calcium oxalate kidney stone formers. Read more about this study
- Who is it for?
- Ages 19 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Kidney Stone
- What is being tested?
- Carbon-13 Oxalate and Sucralose Ingestion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Sep 2021to 1 Aug 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Normal Body Mass Index (≥ 18.5 to < 25); Obese Body Mass Index (≥ 30 to ≤ 45)
- Able to provide informed consent
- Willingness to consume controlled diet
- Composition of most recent stone > 50% calcium oxalate, no uric acid component
- First time or recurrent calcium oxalate stone former
- 24-hour urine collections with creatinine values within 20% of appropriate ratio of creatinine (mg)/body weight (kg) for gender, and with creatinine values that are consistent between collections (within 20% of each other)
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- Willingness to stop supplements [vitamins, Ca (citrate or carbonate) and other minerals, herbal supplements, nutritional aids, probiotics] for 14 days before start and during study
- Willingness to not undertake vigorous exercise during the controlled dietary study
- Normal fasting blood Comprehensive Metabolic Panel
- Hemoglobin A1c < 6.5%
- No food allergies or intolerance to any of the food in study menus
- Permitted/willing to discontinue medications for kidney stone prevention, including thiazides, allopurinol, and febuxostat and citrate preparations, for 14 days before start and during the studies. They will be instructed to restart these medications at the conclusion of the study
Who cannot join
- Diabetes
- Abnormal fasting comprehensive metabolic panel (CMP)
- Hemoglobin A1c (HbA1c) result ≥ 6.5%
- Gout
- Estimated Glomerular Filtration Rate (eGFR) <60 ml/min/1.73m^2
- Primary hyperoxaluria
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- Cystic fibrosis
- Cystinuria
- Uric acid stone former
- Utilization of immunosuppressive medication
- Nephrotic syndrome
- Enteric hyperoxaluria
- Gastrointestinal disorder that could impact oxalate transport
- Sarcoidosis
- Uncontrolled hypertension
- Renal tubular acidosis
- Primary hyperparathyroidism
- Liver disease
- Neurogenic bladder
- Urinary diversion
- Chronic diarrhea
- Bariatric surgery
- Active malignancy or treatment for malignancy within 12 months prior to screening
- Pregnancy
- Breast feeding/nursing
- Females of child bearing age who are not able to use an effective method of birth control during the study
- Mental/medical condition that is likely to impede successful study completion
- Illness including flu / common cold / fever 14 days before study and during study
- Diarrhea or other abnormal gastrointestinal event (e.g. abnormal bowel movements) 14 days before study or during study
- Antibiotic use within last 6 months (based on recommendations of the NIH Human Microbiome Project, Protocol A)
- Inability or unwillingness to undergo MRI
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35243-3353
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
About this study
The primary goals of this study are to determine the contribution of dietary oxalate absorption, renal oxalate handling, and endogenous oxalate synthesis to urinary oxalate excretion in normal Body Mass Index (BMI) and obese calcium oxalate kidney stone formers.
- Conditions
- Kidney Stone
- Being tested
- Controlled Diet, Carbon-13 Oxalate and Sucralose Ingestion
- Keywords
- oxalate, kidney stone
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Controlled DietOther
Participant will consume a controlled low oxalate diet for five days
Carbon-13 Oxalate and Sucralose IngestionDietary supplement
Subjects will ingest a small amount of carbon-13 oxalate and sucralose, dissolved in water.
| Study group | Role | What they receive |
|---|---|---|
| Controlled Dietary Study | Experimental | Participants will consume the controlled diet for five days. After one day on the diet, subjects will provide three 24-hour urine collections. On the last dayof the diet, subjects will come in a fasted state to ingest a small amount of carbon-13 oxalate and sucralose, with hourly urine collections and blood samples being taken before and after the ingestion. Receives: Other: Controlled Diet; Dietary Supplement: Carbon-13 Oxalate and Sucralose Ingestion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary Oxalate Excretion
Urinary oxalate excretion from urine samples will be measured as mg/day
Measured: Baseline through Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2020
- Study start1 Sep 2021
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney StoneStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Texas, Southwestern Medical Center at Dallas
- Responsible party
- Principal investigator, Dean Assimos, MD, University of Alabama at Birmingham
- Investigators
- Dean Assimos, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04333745
- Sponsor's protocol ID
- IRB300004693-OHM
- Other IDs
- P20DK119788, UAB
- Status last verified
- Aug 2026
- First submitted
- 1 Apr 2020
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No