Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
136 participants
INTERVENTIONAL
2021-11-15
2026-12-01
Brief Summary
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Detailed Description
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Adults (≥19 years) with and without a history of calcium oxalate kidney stone disease will be recruited from within the greater Birmingham area, and divided into normal BMI (BMI\<25 kg/m2) and obese (BMI≥30 kg/m2) groups. Following consent, subjects will meet with a dietitian to ensure willingness to consume controlled diets, and provide fasted blood and 2 x 24 hour urine specimens to determine general health status and adequacy of 24-hour urine collections, respectively.
Eligible subjects will consume a low oxalate controlled diet for 6 days, which will involve 2 days of dietary equilibration followed by oral ingestion of 1 mg/kg carbon-13 AA with breakfast on day 3 and subsequent collection of 4 consecutive 24-hour urine specimens. After the carbon-13 AA load, subjects will return each morning to the Clinical Research Unit for a fasted blood draw, to drop off their 24-hour urine collection, and receive their prepared food. In addition, on day 4, 24 hours after ingesting carbon-13 AA, subjects will collect hourly urine and 1/2 hourly blood samples for 5 hours in the Clinical Research Unit.
Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Controlled Dietary Study
Subjects will consume a controlled diet (low in oxalate and ascorbic acid) for six days. After two days of equilibration, subjects will provide a blood sample and ingest an oral load of ascorbic acid (1 mg/kg) with breakfast on Day 3. The following day (Day 4), serial blood and urine collections will occur. On Days 5 through 7, subjects will complete a 24-hr urine collection and blood draw.
Low Oxalate Diet
Subjects will be instructed to ingest a controlled diet low in oxalate for a total of 4 days
Carbon-13 Ascorbic Acid Oral Load
Subjects will be instructed to ingest 1mg/kg of carbon-13 ascorbic acid at breakfast, 2 days after initiating the low oxalate controlled diet.
Interventions
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Low Oxalate Diet
Subjects will be instructed to ingest a controlled diet low in oxalate for a total of 4 days
Carbon-13 Ascorbic Acid Oral Load
Subjects will be instructed to ingest 1mg/kg of carbon-13 ascorbic acid at breakfast, 2 days after initiating the low oxalate controlled diet.
Eligibility Criteria
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Inclusion Criteria
* For stone formers: composition of most recent stone \> 50% calcium oxalate, no uric acid component
* For stone formers: first time or recurrent calcium oxalate stone former with stone event within the prior 3 years
* Two 24-hour urine collections with urinary 24-hour creatinine excretion within 20% of appropriate ratio of creatinine (mg) / body weigh (kg) for gender
* Willingness to stop supplements (vitamins, Calcium (citrate or carbonate) and other minerals, herbal supplements, nutritional aids, probiotics) for 2 weeks before start and during study
* Willingness to not undertake vigorous exercise during the study
* Normal fasting blood Comprehensive Metabolic Panel (CMP)
* Willingness to ingest menus prepared in Clinical Research Unit at University of Alabama at Birmingham
* No food allergies or intolerance to any of the foods in study menus
* If on medications for stone prevention (e.g. thiazides, citrate supplementation excluding calcium citrate), they should have been on a stable dose regimen for at least 8 weeks prior to and during screening, with no changes in dosing anticipated during study protocol. If on allopurinol for stone prevention, stop it for 2 weeks prior to screening and this will not be administered during the study as it has anti-oxidant properties.
Exclusion Criteria
* Gout
* Hypertension
* Estimated Glomerular Filtration Rate (eGFR) less than 60ml/min/1.73m2
* Primary hyperoxaluria
* Nephrotic syndrome
* Enteric hyperoxaluria
* Renal tubular acidosis
* Primary hyperparathyroidism
* Liver disease
* Auto-immune disorder
* Neurogenic bladder
* Urinary diversion
* Bariatric surgery
* Active malignancy or treatment for malignancy within 12 months prior to screening
* Pregnancy
* Breastfeeding/nursing individuals
* 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
* Abnormal fasting CMP
19 Years
ALL
Yes
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
University of Alabama at Birmingham
OTHER
Responsible Party
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John Knight
Principal Investigator
Principal Investigators
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John Knight, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRB-300005614
Identifier Type: -
Identifier Source: org_study_id
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