Effects of Preoperative Long-Term Immunonutrition in Patients Listed for Liver Transplantation
NCT00495859 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 156
Last updated 2008-04-04
Summary
Patients with endstage liver disease characteristically are malnourished which is associated with poor outcome. Formulas enriched with arginine,ω3 fatty acids, and nucleotides potentially improve their nutritional status. This randomized placebo-controlled double blind multicenter clinical trial with longterm preoperative supplementation with such an enriched formula will evaluate evaluate effects of such formulas on patients' quality of life, survival, and posttransplant morbidities.
Conditions
- Newly Registered Patients for Primary Liver Transplantation
Interventions
- DIETARY_SUPPLEMENT
-
Immunonutrition
food for special medical purpose (FSMP)
- DIETARY_SUPPLEMENT
-
food for special medical purposes (FSMP)
an isocaloric isonitrogenous non-specific nutritional support
Sponsors & Collaborators
- collaborator INDUSTRY
-
Heidelberg University
lead OTHER
Principal Investigators
-
Peter Schemmer, MD · Department of Surgery, Ruprecht-Karls University of Heidelberg, Germany
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 68 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-04-30
- Primary Completion
- 2011-04-30
- Completion
- 2011-04-30
Countries
- Germany
Study Locations
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