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NCT03387176
Efficacy of a Gluten-free Diet in Difficult to Manage Nephrotic Syndrome: Utility of Plasma Zonulin Levels as a Predictive Biomarker
trial testing Implementation of a gluten-free diet in Nephrotic Syndrome in 13 participants. Completed in 14 June 2021.
14 June 2021
Quick facts
| Lead sponsor | NYU Langone Health |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 13 |
| Start date | 1 December 2017 |
| Primary completion | 14 June 2021 |
| Estimated completion | 14 June 2021 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Implementation of a gluten-free diet
Conditions studied
- Nephrotic Syndrome — all drugs for Nephrotic Syndrome →
Sponsor
NYU Langone Health — full company profile →
Who can join
Adults 9 Months to 18, any sex, with Nephrotic Syndrome. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03387176
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Nephrotic Syndrome
Currently open trials in the same condition.
- NCT07214818 — SGLT2 Inhibitors in Adult Primary Nephrotic Syndrome · Phase 2, PHASE3 · active not recruiting
- NCT06635720 — REduced-dose Steroid PrOtocol for Childhood Nephrotic SyndromE (RESPONSE) · Phase 3 · recruiting
- NCT06622915 — Cardiac Performance Evaluation in Children With Steroid Dependent vs Steroid Resistant Nephrotic Syndrome · NA · recruiting
- NCT06161701 — Steroid Diabetes in Patients With Kidney Disease · recruiting
- NCT06373913 — The Role of Proprotein-convertase-subtilisin/Kexin-type 9 in Kidney Damage in Nephrotic Syndrom · recruiting
Other NYU Langone Health trials
Trials by the same sponsor.
- NCT07214519 — Permanent Supportive Housing Overdose Prevention-2 Study · NA · not yet recruiting
- NCT05558267 — Potassium Containing Salt-Substitute in Hemodialysis-Dependent End Stage Kidney Disease · NA · not yet recruiting
- NCT06637852 — Sexual and Urinary Function Improvement for Cancer Survivors · NA · not yet recruiting
- NCT06236087 — Overdose Prevention Centers and Behavioral Health · not yet recruiting
- NCT06462027 — Packed Red Blood Cell Transfusion During Cardiac Arrest · Phase 1 · suspended
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03387176 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by NYU Langone Health
- Last refreshed: 22 June 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03387176.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing