The HOME Study (HPN With OMEGA-3)

Phase 4

Completed

• Conditions: Patients Requiring Home Parenteral Nutrition
• Interventions: Drug: Lipidem; Drug: Lipofundin MCT 20%

• Registration Number: NCT03282955
• Lead Sponsor: B. Braun Melsungen AG

Brief Summary

The aim of the trial is to investigate safety and tolerability of an Omega-3-FA-enriched lipid emulsion in adult patients with chronic intestinal failure in need of long-term HPN. It is aimed to show non-inferiority of the lipid emulsion Lipidem (investigational test product) in comparison to the lipid emulsion Lipofundin MCT (investigational reference product) with regard to liver function.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-10
• Study First Submitted QC: 2017-09-13
• Study First Posted: 2017-09-14
• Study Start: 2018-01-08
• Primary Completion: 2022-07-19
• Study Completion: 2022-07-19
• Results First Submitted: 2025-05-12
• Status Verified: 2025-06
• Results First Submitted QC: 2025-06-11
• Last Update Submitted: 2025-06-11
• Results First Posted: 2025-07-04
• Last Update Posted: 2025-07-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lipidem	Lipidem	i.v. lipid emulsion containing fractionated fish oil (n-3 fatty acid triglycerides)
Lipofundin MCT	Lipofundin MCT 20%	i.v. lipid emulsion

Primary Outcome Measures

Name	Time	Method
Change of Liver Function Parameters From Baseline to Visit 2	8 weeks	Changes will be expressed as the sum of the N(0.1)- transformed differences of bilirubin, ALT and AST (from Baseline to Visit 2), i.e. for all three parameters each change of the value is subtracted by the mean change of the respective parameter. This difference is divided by the standard deviation of the change, which results in a unitless normalised value. All values for the 3 liver parameters (bilirubin, ALT and AST) will be added. The final sum reflects the change of liver function parameters.

Secondary Outcome Measures

Name	Time	Method
Bilirubin	8 weeks	Change from baseline
Alanine Transaminase (ALT)	8 weeks	Change from baseline
Aspartate Transaminase (AST)	8 weeks	Change from baseline
AST/ALT Ratio	8 weeks	Change from baseline
Alkaline Phosphatase (ALP)	8 weeks	Change from baseline
Gamma-glutamyl Transpeptidase (GGT)	8 weeks	Change from baseline
White Blood Cells (WBCs)	8 weeks	Change from baseline
Red Blood Cells (RBCs)	8 weeks	Change from baseline
International Normalized Ratio (INR) (if Not Possible Prothrombin Time [PT = Quick-value] is Accepted)	8 weeks	Change from baseline
Potassium	8 weeks	Change from baseline
Calcium	8 weeks	Change from baseline
Hemoglobin (Hb)	8 weeks	Change from baseline
Blood Glucose	8 weeks	Change from baseline
Cholesterol	8 weeks	Change from baseline
High-density Lipoprotein (HDL)	8 weeks	Change from baseline
Low-density Lipoprotein (LDL)	8 weeks	Change from baseline
Platelets	8 weeks	Change from baseline
Activated Partial Thromboplastin Time (aPTT)	8 weeks	Change from baseline
Hematocrit (Hct)	8 weeks	Change from baseline
Sodium	8 weeks	Change from baseline
Chloride	8 weeks	Change from baseline
Magnesium	8 weeks	Change from baseline
Phosphate	8 weeks	Change from baseline
Serum Creatinine	8 weeks	Change from baseline
Triglycerides	8 weeks	Change from baseline
α-Tocopherol/Vitamin E (Facultative if Routinely Assessed)	8 weeks	Change from baseline
Adverse Events	8 weeks	Number of adverse events (including serious adverse events)
C-reactive Protein (CRP)	8 weeks	Change from baseline
Triene:Tetraene Ratio in Plasma, Reduction From Baseline	8 weeks	Derived from fatty acid pattern in plasma
BMI	8 weeks	Body mass index Change from baseline
Prothrombin Time (PT)	8 weeks	Change from baseline

Trial Locations

Locations (9)

Hôpital Archet 2 - Unité de support nutritionnel; 🇫🇷 Nice, France

Hospices Civiles de Lyon - Centre hospitalier Lyon Sud; 🇫🇷 Pierre-Bénite, France

Department of Medical and Surgical Science, University of Bologna, Center for Chronic Intestinal Failure, Department of Digestive System, St. Orsola-Malpighi Hospital; 🇮🇹 Bologna, Italy

Radboud university medical center; 🇳🇱 Nijmegen, Netherlands

Stanley Dudrick's Memorial Hospital; 🇵🇱 Skawina, Poland

Samodzielny Publiczny Szpital Kliniczny, im. prof. dr W. Orlowskiego, Centrum Medycznego Ksztalcenia Podyplomowego, Oddzial Kliniczny Zywienia i Chirurgii; 🇵🇱 Warszawa, Poland

Wojewódzkim Specjalistycznym Szpitalem im. M. Pirogowa w Łodzi , Oddział Chirurgii Ogólnej i Naczyniowej; 🇵🇱 Łódź, Poland

University Hospitals Birmingham NHS Foundation Trust; 🇬🇧 Birmingham, United Kingdom

University College Hospital London; 🇬🇧 London, United Kingdom