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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK128842 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Controls | Active Comparator |
| |
| Enteric Hyperoxaluria | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moderately High Oxalate (MOx) Diet | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary Oxalate Levels (UOx) | UOx will be quantified in 24-h samples | Day 2-3 |
| Urinary Oxalate Levels (UOx) | UOx will be quantified in 24-h samples | Day 23-24 |
| Measure | Description | Time Frame |
|---|---|---|
| Total Fecal Oxalate Levels | Day 2-3 | |
| Total Fecal Oxalate Levels | Day 14 | |
| Total Fecal Oxalate Levels |
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Inclusion Criteria:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lama Nazzal, MD | Contact | 212-263-2922 | Lama.Nazzal@nyulangone.org | |
| David Goldfarb, MD | Contact | 212-263-0744 | David.Goldfarb@nyulangone.org |
| Name | Affiliation | Role |
|---|---|---|
| Lama Nazzal, MD | NYU Langone Health | Study Chair |
| David Goldfarb, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | Recruiting | New York | New York | 10016 | United States |
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.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to lama.nazzal@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
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| ID | Term |
|---|---|
| D004032 | Diet |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Day 23-24 |
| Urinary Calcium Levels | Day 2-3 |
| Urinary Calcium Levels | Day 23-24 |
| Sucralose Levels | Day 2-3 |
| Sucralose Levels | Day 23-24 |
| Calcium Oxalate (CaOx) Supersaturation Levels | Day 2-3 |
| Calcium Oxalate (CaOx) Supersaturation Levels | Day 23-24 |
| Plasma Oxalate Levels | Day 2-3 |
| Plasma Oxalate Levels | Day 23-24 |