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NCT03493204
Tackling 30-day Readmissions in Patients With Cirrhosis: The SALTYFOOD Trial
NA trial testing Meal delivery in Hepatic Encephalopathy in 44 participants. Completed in 19 August 2019.
19 August 2019
Quick facts
| Lead sponsor | University of Michigan |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 44 |
| Start date | 24 April 2018 |
| Primary completion | 19 August 2019 |
| Estimated completion | 19 August 2019 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Meal delivery
- Standard pamphlet with Dietary Advice
Conditions studied
- Hepatic Encephalopathy — all drugs for Hepatic Encephalopathy →
- Ascites — all drugs for Ascites →
- Liver Diseases — all drugs for Liver Diseases →
- Cirrhosis — all drugs for Cirrhosis →
Sponsor
University of Michigan
Who can join
18 and older, any sex, with Hepatic Encephalopathy or Ascites. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to determine the feasibility of a home meal delivery program for patients with cirrhosis and ascites and to determine the effectiveness of a salt-restricted (2 gram sodium) meal delivery program in reducing the need for therapeutic paracenteses and/or all-cause re-admissions for these patients. Many patients with cirrhosis don't have enough nutrients in the body and are frail and these meals may help them maintain a good diet and lead to improved quality of life.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Medically tailored meals for the management of symptomatic ascites: the SALTYFOOD pilot randomized clinical trial.
Tapper EB, Baki J, Nikirk S, Hummel S, et al · · 2020 · cited 19× · PMID 33442478 · DOI 10.1093/gastro/goaa059 -
Design and rationale of a randomized-controlled trial of home-delivered meals for the management of symptomatic ascites: the SALTYFOOD trial.
Tapper EB, Baki J, Hummel S, Lok A. · · 2019 · cited 4× · PMID 30976428 · DOI 10.1093/gastro/goz005
Verify or expand the search:
- PubMed search for NCT03493204
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Meal delivery
Trials testing the same drug.
- NCT04810026 — Transform Type 2: Examining Meal-Delivery and Education for Diabetes Self-Care · NA · completed
Other recruiting trials for Hepatic Encephalopathy
Currently open trials in the same condition.
- NCT07521332 — Apixaban-PK Trial: Preventing Portal Hypertension Complications in Cirrhosis · Phase 4 · recruiting
- NCT07418008 — The Liver Cirrhosis Cognitive Decline Scale (LiCCoS) · recruiting
- NCT06953921 — Correlation Between Serum Albumin Level and Severity of Hepatic Encephalopathy in Patients With Chronic Liver Disease in · recruiting
- NCT07437638 — Clinical Efficacy and Survival Prediction Analysis of Transjugular Intrahepatic Portosystemic Shunt in Patients With Liv · active not recruiting
- NCT06425380 — Pilot Open-Label Trial of Resistant Potato Starch in Patients With Cirrhosis and Overt Hepatic Encephalopathy · NA · recruiting
Other University of Michigan trials
Trials by the same sponsor.
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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 NCT03493204 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Michigan
- Last refreshed: 30 August 2019
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/NCT03493204.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing