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Parenteral Lipid Emulsions and the Liver Function

NCT03044639 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2017-02-07

No results posted yet for this study

Summary

The randomized, double-blind, multi-centric study performed in four parallel groups to compare all lipid emulsions, which can be used as a part of PN. Patients with home parenteral nutrition due to stable intestinal failure, were randomly assigned to receive parenteral nutrition with one the following lipid emulsions:

* Long-chained triglycerides (LCT group)
* Medium/ long-chained triglycerides MCT/LCT (50:50, MCT/LCT group))
* Olive oil/ LCT (80:20, OO group))
* SMOFlipid (Omega-3/ olive oil/ MCT/ LCT, SMOF group)

Conditions

  • Liver Failure

Interventions

DRUG

Lipid Emulsions, Intravenous

The every day provision of lipid emulsion as a part of parenteral nutrition along with dextrose, amino acids, electrolytes, trace elements, vitamins and water in the dose of 0.8-1.0 g/kg/day.

Sponsors & Collaborators

  • Stanley Dudrick's Memorial Hospital

    lead OTHER

Principal Investigators

  • Stanislaw Klek, MD PhD · Stanley Dudrick's Memorial Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-01
Primary Completion
2016-10-31
Completion
2016-12-31

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03044639 on ClinicalTrials.gov