An interventional study of Moderately High Oxalate (MOx) Diet in Enteric Hyperoxaluria, sponsored by NYU Langone Health. Recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-07.
Sponsored by NYU Langone Health · Not applicable, Interventional, and Other
40 subjects with a confirmed diagnosis of IBD or >6 months post-RYGB with a diagnosed USD event or kidney stone on imaging within the past three years and 40 healthy controls will be administered a high oxalate diet on Days 0-3 and Days 21-24 with a washout period on Days 4-7 and will be administered 250mg sodium oxalate on Days 8-20, via prepared spinach, from Weil Cornell Medicine's Clinical and Translational Science Center. Subjects will partake in four stool collections, four 24-h urine collections, two blood collections, and four sets of colonic permeability testing.
NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.
Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.
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In order to be eligible to participate in this study, an individual must meet all of the following criteria:
In order to be eligible in this study as a healthy control, an individual must meet all of the following criteria:
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
An individual who meets any of the following criteria will be excluded from participation in this study as a healthy control:
Other: Moderately High Oxalate (MOx) Diet
Other: Moderately High Oxalate (MOx) Diet
Diets will contain 16% protein, 30% fat, and 54% carbohydrate, and are controlled in the amounts of calcium (400mg), oxalate (250mg), ascorbic acid (50mg), fiber (30 grams) and, other nutrients. Each controlled diet will be consumed for four days. On days of controlled diets, subjects will be provided with 2 liters of bottled water per day to ensure adequate hydration. After the controlled diet period, there will be a three-day washout period, where participants will consume Ad-lib diets supplemented with a daily intake of oxalate in the form of cooked spinach to be taken with breakfast daily for a total of 2 weeks.
Urinary Oxalate Levels (UOx)
UOx will be quantified in 24-h samples
Time frame: Day 2-3
Urinary Oxalate Levels (UOx)
UOx will be quantified in 24-h samples
Time frame: Day 23-24
Total Fecal Oxalate Levels
Time frame: Day 2-3
Total Fecal Oxalate Levels
Time frame: Day 14
Total Fecal Oxalate Levels
Time frame: Day 23-24
Urinary Calcium Levels
Time frame: Day 2-3
Urinary Calcium Levels
Time frame: Day 23-24
Sucralose Levels
Time frame: Day 2-3
Sucralose Levels
Time frame: Day 23-24
Calcium Oxalate (CaOx) Supersaturation Levels
Time frame: Day 2-3
Calcium Oxalate (CaOx) Supersaturation Levels
Time frame: Day 23-24
Plasma Oxalate Levels
Time frame: Day 2-3
Plasma Oxalate Levels
Time frame: Day 23-24
Plan to share: Yes — Data collected for this study will be analyzed and stored at the Nazzal-hyperoxaluria data repository. After the study is completed, the de-identified, archived data will and stored at the Nazzal- hyperoxaluria data repository, under the supervision of Dr. Lama Nazzal, for use by other researchers including those outside of the study. Permission to transmit data to the Nazzal-hyperoxaluria data repository will be included in the informed consent. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) upon reasonable request.
Supporting information: Study protocol, Sap
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