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NCT03387176 · ClinicalTrials.gov registry record
Efficacy of a Gluten-free Diet in Difficult to Manage Nephrotic Syndrome: Utility of Plasma Zonulin Levels as a Predictive Biomarker
A clinical trial, sponsored by NYU Langone Health.
- Completed
- Registry status
- 13
- Enrollment target
NCT03387176 is a clinical trial that has completed, run by NYU Langone Health. The registered enrollment target is 13 participants.
The verdict
NCT03387176 has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- 13 participants
- Enrollment target
Study Summary
Elevated plasma zonulin levels, which are supportive of a diagnosis of CD (celiac disease) in children with gastrointestinal symptoms, may indicate patients with difficult-to-manage NS who will benefit from initiation of a GFD (gluten free diet). This pilot study will determine whether high plasma zonulin levels can be used as a screening tool to identify patients with NS (nephrotic syndrome) who are likely to demonstrate a beneficial response to a GFD. It will provide important information about the feasibility of testing the efficacy of a GFD for this condition and assist in the design and sample size calculation for a definitive trial to test the beneficial effect of this dietary intervention. Although NS is a rare condition in childhood, it is a chronic disease that can lead to short- and long-term disability especially in those with difficult-to-manage disease. There is an urgent need to develop safe and effective new therapies in this subgroup. This project may indicate the utility of a common dietary modification, a GFD, to treat these patients. The growing medical use of and greater access to gluten-free food items underscore the feasibility and timeliness of this approach.
Interventions
- OTHER Implementation of a gluten-free diet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2017-12-01 |
| Est. Completion | 2021-06-14 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03387176
The ClinicalTrials.gov registry entry for NCT03387176 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Implementation of a gluten-free diet is the first listed.
NCT03387176 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03387176 about?
NCT03387176 is a clinical study titled "Efficacy of a Gluten-free Diet in Difficult to Manage Nephrotic Syndrome: Utility of Plasma Zonulin Levels as a Predictive Biomarker". Elevated plasma zonulin levels, which are supportive of a diagnosis of CD (celiac disease) in children with gastrointestinal symptoms, may indicate patients with difficult-to-manage NS who will benefit from initiation of a GFD (gluten free diet). This pilot study will determine whether high plasma z...
What is the current status of trial NCT03387176?
This trial is currently completed. The enrollment target is 13 participants. The study started on 2017-12-01. Estimated completion is 2021-06-14.
What interventions are being tested in trial NCT03387176?
The interventions under investigation include: Implementation of a gluten-free diet (OTHER).
Who is sponsoring clinical trial NCT03387176?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
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