Oxalate Formation From Ascorbic Acid
Running, not enrolling · Not applicable
Conditions studied: Kidney Stone
In brief
The purpose of this basic research study is to determine the contribution of endogenous ascorbic acid (AA) turnover to urinary oxalate excretion in both normal BMI and obese adult non-stone formers and calcium oxalate stone formers. The studies proposed will use diets of known nutrient composition, a stable isotope of ascorbic acid (13C6-AA) and mass spectrometric techniques to quantify ascorbic acid turnover to oxalate.
Key facts
- Study ID
- NCT04603898
- Run by
- University of Alabama at Birmingham
- People needed
- 90
- Starts
- 2021-11-15
- Expected to finish
- 2027-02-01
- Last updated by the study team
- 2026-06-09
Who can join
Age: 19 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Able to provide informed consent
- 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.
You may not qualify if…
- Diabetes
- 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
Where it is running
- University of Alabama at Birmingham — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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