Trial Outcomes & Findings for The HOME Study (HPN With OMEGA-3) (NCT NCT03282955)

NCT ID: NCT03282955

Last Updated: 2025-07-04

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 74 participants
• Primary outcome timeframe: 8 weeks
• Results posted on: 2025-07-04

Participant Flow

Participant milestones

Measure	Lipidem i.v. lipid emulsion containing fractionated fish oil (n-3 fatty acid triglycerides) Lipidem: Lipoplus i.v. lipid emulsion for parenteral nutrition	Lipofundin MCT i.v. lipid emulsion Lipofundin MCT 20%: Lipofundin MCT 20% i.v. lipid emulsion for parenteral nutrition
Overall Study STARTED	40	34
Overall Study COMPLETED	35	30
Overall Study NOT COMPLETED	5	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The HOME Study (HPN With OMEGA-3)

Baseline characteristics by cohort

Measure	Lipidem n=38 Participants i.v. lipid emulsion containing fractionated fish oil (n-3 fatty acid triglycerides) Lipidem: Lipoplus i.v. lipid emulsion for parenteral nutrition	Lipofundin MCT n=34 Participants i.v. lipid emulsion Lipofundin MCT 20%: Lipofundin MCT 20% i.v. lipid emulsion for parenteral nutrition	Total n=72 Participants Total of all reporting groups
Age, Continuous	50.13 years STANDARD_DEVIATION 15.82 • n=5 Participants	52.44 years STANDARD_DEVIATION 15.50 • n=7 Participants	51.22 years STANDARD_DEVIATION 15.60 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	24 Participants n=7 Participants	40 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	10 Participants n=7 Participants	32 Participants n=5 Participants
Race/Ethnicity, Customized White	35 Participants n=5 Participants	31 Participants n=7 Participants	66 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian/Other Pacific	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Missing	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment Netherlands	4 participants n=5 Participants	3 participants n=7 Participants	7 participants n=5 Participants
Region of Enrollment Poland	20 participants n=5 Participants	16 participants n=7 Participants	36 participants n=5 Participants
Region of Enrollment Italy	2 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants
Region of Enrollment United Kingdom	2 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants
Region of Enrollment France	10 participants n=5 Participants	11 participants n=7 Participants	21 participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: Full Analysis Set

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.

Outcome measures

Measure	Lipidem n=36 Participants i.v. lipid emulsion containing fractionated fish oil (n-3 fatty acid triglycerides) Lipidem: Lipoplus i.v. lipid emulsion for parenteral nutrition	Lipofundin MCT n=31 Participants i.v. lipid emulsion Lipofundin MCT 20%: Lipofundin MCT 20% i.v. lipid emulsion for parenteral nutrition
Change of Liver Function Parameters From Baseline to Visit 2	0.0606 normalized sum- no unit Standard Deviation 3.0876	-0.0703 normalized sum- no unit Standard Deviation 1.8063

SECONDARY outcome

Timeframe: 8 weeks

Change from baseline

Outcome measures

Measure	Lipidem n=36 Participants i.v. lipid emulsion containing fractionated fish oil (n-3 fatty acid triglycerides) Lipidem: Lipoplus i.v. lipid emulsion for parenteral nutrition	Lipofundin MCT n=31 Participants i.v. lipid emulsion Lipofundin MCT 20%: Lipofundin MCT 20% i.v. lipid emulsion for parenteral nutrition
Bilirubin	0.36 µmol/L Standard Deviation 3.34	0.04 µmol/L Standard Deviation 3.26

SECONDARY outcome

Timeframe: 8 weeks

Change from baseline

Outcome measures

Measure	Lipidem n=36 Participants i.v. lipid emulsion containing fractionated fish oil (n-3 fatty acid triglycerides) Lipidem: Lipoplus i.v. lipid emulsion for parenteral nutrition	Lipofundin MCT n=31 Participants i.v. lipid emulsion Lipofundin MCT 20%: Lipofundin MCT 20% i.v. lipid emulsion for parenteral nutrition
Alanine Transaminase (ALT)	0.06 µkat/L Standard Deviation 0.60	0.01 µkat/L Standard Deviation 0.25

SECONDARY outcome

Timeframe: 8 weeks

Change from baseline

Outcome measures

Measure	Lipidem n=36 Participants i.v. lipid emulsion containing fractionated fish oil (n-3 fatty acid triglycerides) Lipidem: Lipoplus i.v. lipid emulsion for parenteral nutrition	Lipofundin MCT n=31 Participants i.v. lipid emulsion Lipofundin MCT 20%: Lipofundin MCT 20% i.v. lipid emulsion for parenteral nutrition
Aspartate Transaminase (AST)	-0.03 µkat/L Standard Deviation 0.38	-0.00 µkat/L Standard Deviation 0.21

SECONDARY outcome

Timeframe: 8 weeks

Change from baseline

Outcome measures

Measure	Lipidem n=34 Participants i.v. lipid emulsion containing fractionated fish oil (n-3 fatty acid triglycerides) Lipidem: Lipoplus i.v. lipid emulsion for parenteral nutrition	Lipofundin MCT n=31 Participants i.v. lipid emulsion Lipofundin MCT 20%: Lipofundin MCT 20% i.v. lipid emulsion for parenteral nutrition
AST/ALT Ratio	0.53 Ratio Standard Deviation 1.00	0.89 Ratio Standard Deviation 2.52

SECONDARY outcome

Timeframe: 8 weeks

Change from baseline

Outcome measures

Measure	Lipidem n=34 Participants i.v. lipid emulsion containing fractionated fish oil (n-3 fatty acid triglycerides) Lipidem: Lipoplus i.v. lipid emulsion for parenteral nutrition	Lipofundin MCT n=30 Participants i.v. lipid emulsion Lipofundin MCT 20%: Lipofundin MCT 20% i.v. lipid emulsion for parenteral nutrition
Alkaline Phosphatase (ALP)	0.13 µkat/L Standard Deviation 0.66	-0.15 µkat/L Standard Deviation 1.46

SECONDARY outcome

Timeframe: 8 weeks

Population: Safety Set

Change from baseline

Outcome measures

Measure	Lipidem n=35 Participants i.v. lipid emulsion containing fractionated fish oil (n-3 fatty acid triglycerides) Lipidem: Lipoplus i.v. lipid emulsion for parenteral nutrition	Lipofundin MCT n=30 Participants i.v. lipid emulsion Lipofundin MCT 20%: Lipofundin MCT 20% i.v. lipid emulsion for parenteral nutrition
Gamma-glutamyl Transpeptidase (GGT)	0.02 µkat/L Standard Deviation 0.38	-0.11 µkat/L Standard Deviation 1.64

SECONDARY outcome

Timeframe: 8 weeks

Change from baseline

Outcome measures

Measure	Lipidem n=34 Participants i.v. lipid emulsion containing fractionated fish oil (n-3 fatty acid triglycerides) Lipidem: Lipoplus i.v. lipid emulsion for parenteral nutrition	Lipofundin MCT n=31 Participants i.v. lipid emulsion Lipofundin MCT 20%: Lipofundin MCT 20% i.v. lipid emulsion for parenteral nutrition
White Blood Cells (WBCs)	0.45 10^9 cells/L Standard Deviation 1.42	0.19 10^9 cells/L Standard Deviation 1.39

SECONDARY outcome

Timeframe: 8 weeks

Change from baseline

Outcome measures

Measure	Lipidem n=34 Participants i.v. lipid emulsion containing fractionated fish oil (n-3 fatty acid triglycerides) Lipidem: Lipoplus i.v. lipid emulsion for parenteral nutrition	Lipofundin MCT n=31 Participants i.v. lipid emulsion Lipofundin MCT 20%: Lipofundin MCT 20% i.v. lipid emulsion for parenteral nutrition
Red Blood Cells (RBCs)	-0.02 10^12 cells/L Standard Deviation 0.28	-0.10 10^12 cells/L Standard Deviation 0.28

SECONDARY outcome

Timeframe: 8 weeks

Change from baseline

Outcome measures

Measure	Lipidem n=34 Participants i.v. lipid emulsion containing fractionated fish oil (n-3 fatty acid triglycerides) Lipidem: Lipoplus i.v. lipid emulsion for parenteral nutrition	Lipofundin MCT n=31 Participants i.v. lipid emulsion Lipofundin MCT 20%: Lipofundin MCT 20% i.v. lipid emulsion for parenteral nutrition
Hemoglobin (Hb)	0.52 g/L Standard Error 8.82	-1.75 g/L Standard Error 8.22

SECONDARY outcome

Timeframe: 8 weeks

Change from baseline

Outcome measures

Measure	Lipidem n=34 Participants i.v. lipid emulsion containing fractionated fish oil (n-3 fatty acid triglycerides) Lipidem: Lipoplus i.v. lipid emulsion for parenteral nutrition	Lipofundin MCT n=31 Participants i.v. lipid emulsion Lipofundin MCT 20%: Lipofundin MCT 20% i.v. lipid emulsion for parenteral nutrition
Platelets	3.06 10^9 cells/L Standard Deviation 41.11	6.90 10^9 cells/L Standard Deviation 50.33

SECONDARY outcome

Timeframe: 8 weeks

Change from baseline

Outcome measures

Measure	Lipidem n=27 Participants i.v. lipid emulsion containing fractionated fish oil (n-3 fatty acid triglycerides) Lipidem: Lipoplus i.v. lipid emulsion for parenteral nutrition	Lipofundin MCT n=25 Participants i.v. lipid emulsion Lipofundin MCT 20%: Lipofundin MCT 20% i.v. lipid emulsion for parenteral nutrition
International Normalized Ratio (INR) (if Not Possible Prothrombin Time [PT = Quick-value] is Accepted)	-0.01 Ratio Standard Deviation 0.25	-0.16 Ratio Standard Deviation 0.71

SECONDARY outcome

Timeframe: 8 weeks

Change from baseline

Outcome measures

Measure	Lipidem n=25 Participants i.v. lipid emulsion containing fractionated fish oil (n-3 fatty acid triglycerides) Lipidem: Lipoplus i.v. lipid emulsion for parenteral nutrition	Lipofundin MCT n=19 Participants i.v. lipid emulsion Lipofundin MCT 20%: Lipofundin MCT 20% i.v. lipid emulsion for parenteral nutrition
Activated Partial Thromboplastin Time (aPTT)	0.02 seconds Standard Deviation 3.85	0.97 seconds Standard Deviation 7.69

SECONDARY outcome

Timeframe: 8 weeks

Change from baseline

Outcome measures

Measure	Lipidem n=34 Participants i.v. lipid emulsion containing fractionated fish oil (n-3 fatty acid triglycerides) Lipidem: Lipoplus i.v. lipid emulsion for parenteral nutrition	Lipofundin MCT n=31 Participants i.v. lipid emulsion Lipofundin MCT 20%: Lipofundin MCT 20% i.v. lipid emulsion for parenteral nutrition
Hematocrit (Hct)	-0.00 L/L Standard Deviation 0.03	-0.01 L/L Standard Deviation 0.03

SECONDARY outcome

Timeframe: 8 weeks

Change from baseline

Outcome measures

Measure	Lipidem n=32 Participants i.v. lipid emulsion containing fractionated fish oil (n-3 fatty acid triglycerides) Lipidem: Lipoplus i.v. lipid emulsion for parenteral nutrition	Lipofundin MCT n=31 Participants i.v. lipid emulsion Lipofundin MCT 20%: Lipofundin MCT 20% i.v. lipid emulsion for parenteral nutrition
Blood Glucose	0.43 mmol/L Standard Deviation 0.94	-0.14 mmol/L Standard Deviation 1.33

SECONDARY outcome

Timeframe: 8 weeks

Change from baseline

Outcome measures

Measure	Lipidem n=35 Participants i.v. lipid emulsion containing fractionated fish oil (n-3 fatty acid triglycerides) Lipidem: Lipoplus i.v. lipid emulsion for parenteral nutrition	Lipofundin MCT n=31 Participants i.v. lipid emulsion Lipofundin MCT 20%: Lipofundin MCT 20% i.v. lipid emulsion for parenteral nutrition
Sodium	0.18 mmol/L Standard Deviation 2.67	-0.58 mmol/L Standard Deviation 2.74

SECONDARY outcome

Timeframe: 8 weeks

Change from baseline

Outcome measures

Measure	Lipidem n=35 Participants i.v. lipid emulsion containing fractionated fish oil (n-3 fatty acid triglycerides) Lipidem: Lipoplus i.v. lipid emulsion for parenteral nutrition	Lipofundin MCT n=31 Participants i.v. lipid emulsion Lipofundin MCT 20%: Lipofundin MCT 20% i.v. lipid emulsion for parenteral nutrition
Chloride	-0.19 mmol/L Standard Deviation 3.33	-0.15 mmol/L Standard Deviation 4.08

SECONDARY outcome

Timeframe: 8 weeks

Change from baseline

Outcome measures

Measure	Lipidem n=35 Participants i.v. lipid emulsion containing fractionated fish oil (n-3 fatty acid triglycerides) Lipidem: Lipoplus i.v. lipid emulsion for parenteral nutrition	Lipofundin MCT n=31 Participants i.v. lipid emulsion Lipofundin MCT 20%: Lipofundin MCT 20% i.v. lipid emulsion for parenteral nutrition
Potassium	0.06 mmol/L Standard Deviation 0.37	0.01 mmol/L Standard Deviation 0.46

SECONDARY outcome

Timeframe: 8 weeks

Change from baseline

Outcome measures

Measure	Lipidem n=35 Participants i.v. lipid emulsion containing fractionated fish oil (n-3 fatty acid triglycerides) Lipidem: Lipoplus i.v. lipid emulsion for parenteral nutrition	Lipofundin MCT n=31 Participants i.v. lipid emulsion Lipofundin MCT 20%: Lipofundin MCT 20% i.v. lipid emulsion for parenteral nutrition
Calcium	-0.01 mmol/L Standard Deviation 0.15	-0.01 mmol/L Standard Deviation 0.10

SECONDARY outcome

Timeframe: 8 weeks

Change from baseline

Outcome measures

Measure	Lipidem n=35 Participants i.v. lipid emulsion containing fractionated fish oil (n-3 fatty acid triglycerides) Lipidem: Lipoplus i.v. lipid emulsion for parenteral nutrition	Lipofundin MCT n=30 Participants i.v. lipid emulsion Lipofundin MCT 20%: Lipofundin MCT 20% i.v. lipid emulsion for parenteral nutrition
Magnesium	0.00 mmol/L Standard Deviation 0.09	-0.00 mmol/L Standard Deviation 0.06

SECONDARY outcome

Timeframe: 8 weeks

Change from baseline

Outcome measures

Measure	Lipidem n=34 Participants i.v. lipid emulsion containing fractionated fish oil (n-3 fatty acid triglycerides) Lipidem: Lipoplus i.v. lipid emulsion for parenteral nutrition	Lipofundin MCT n=30 Participants i.v. lipid emulsion Lipofundin MCT 20%: Lipofundin MCT 20% i.v. lipid emulsion for parenteral nutrition
Phosphate	-0.02 mmol/L Standard Deviation 0.18	-0.00 mmol/L Standard Deviation 0.16

SECONDARY outcome

Timeframe: 8 weeks

Change from baseline

Outcome measures

Measure	Lipidem n=35 Participants i.v. lipid emulsion containing fractionated fish oil (n-3 fatty acid triglycerides) Lipidem: Lipoplus i.v. lipid emulsion for parenteral nutrition	Lipofundin MCT n=31 Participants i.v. lipid emulsion Lipofundin MCT 20%: Lipofundin MCT 20% i.v. lipid emulsion for parenteral nutrition
Serum Creatinine	3.87 µmol/L Standard Deviation 32.42	0.43 µmol/L Standard Deviation 9.23

SECONDARY outcome

Timeframe: 8 weeks

Change from baseline

Outcome measures

Measure	Lipidem n=36 Participants i.v. lipid emulsion containing fractionated fish oil (n-3 fatty acid triglycerides) Lipidem: Lipoplus i.v. lipid emulsion for parenteral nutrition	Lipofundin MCT n=30 Participants i.v. lipid emulsion Lipofundin MCT 20%: Lipofundin MCT 20% i.v. lipid emulsion for parenteral nutrition
Triglycerides	0.10 mmol/L Standard Deviation 0.55	0.19 mmol/L Standard Deviation 0.68

SECONDARY outcome

Timeframe: 8 weeks

Change from baseline

Outcome measures

Measure	Lipidem n=36 Participants i.v. lipid emulsion containing fractionated fish oil (n-3 fatty acid triglycerides) Lipidem: Lipoplus i.v. lipid emulsion for parenteral nutrition	Lipofundin MCT n=30 Participants i.v. lipid emulsion Lipofundin MCT 20%: Lipofundin MCT 20% i.v. lipid emulsion for parenteral nutrition
Cholesterol	0.01 mmol/L Standard Deviation 0.39	0.02 mmol/L Standard Deviation 0.71

SECONDARY outcome

Timeframe: 8 weeks

Change from baseline

Outcome measures

Measure	Lipidem n=36 Participants i.v. lipid emulsion containing fractionated fish oil (n-3 fatty acid triglycerides) Lipidem: Lipoplus i.v. lipid emulsion for parenteral nutrition	Lipofundin MCT n=30 Participants i.v. lipid emulsion Lipofundin MCT 20%: Lipofundin MCT 20% i.v. lipid emulsion for parenteral nutrition
High-density Lipoprotein (HDL)	-0.12 mmol/L Standard Deviation 0.19	0.03 mmol/L Standard Deviation 0.23

SECONDARY outcome

Timeframe: 8 weeks

Change from baseline

Outcome measures

Measure	Lipidem n=36 Participants i.v. lipid emulsion containing fractionated fish oil (n-3 fatty acid triglycerides) Lipidem: Lipoplus i.v. lipid emulsion for parenteral nutrition	Lipofundin MCT n=30 Participants i.v. lipid emulsion Lipofundin MCT 20%: Lipofundin MCT 20% i.v. lipid emulsion for parenteral nutrition
Low-density Lipoprotein (LDL)	0.07 mmol/L Standard Deviation 0.33	-0.08 mmol/L Standard Deviation 0.76

SECONDARY outcome

Timeframe: 8 weeks

Change from baseline

Outcome measures

Measure	Lipidem n=35 Participants i.v. lipid emulsion containing fractionated fish oil (n-3 fatty acid triglycerides) Lipidem: Lipoplus i.v. lipid emulsion for parenteral nutrition	Lipofundin MCT n=30 Participants i.v. lipid emulsion Lipofundin MCT 20%: Lipofundin MCT 20% i.v. lipid emulsion for parenteral nutrition
C-reactive Protein (CRP)	37.16 nmol/L Standard Deviation 160.03	-24.65 nmol/L Standard Deviation 209.18

SECONDARY outcome

Timeframe: 8 weeks

Change from baseline

Outcome measures

Measure	Lipidem n=4 Participants i.v. lipid emulsion containing fractionated fish oil (n-3 fatty acid triglycerides) Lipidem: Lipoplus i.v. lipid emulsion for parenteral nutrition	Lipofundin MCT n=5 Participants i.v. lipid emulsion Lipofundin MCT 20%: Lipofundin MCT 20% i.v. lipid emulsion for parenteral nutrition
α-Tocopherol/Vitamin E (Facultative if Routinely Assessed)	-3.00 µmol/L] Standard Deviation 6.60	-1.94 µmol/L] Standard Deviation 10.99

SECONDARY outcome

Timeframe: 8 weeks

Derived from fatty acid pattern in plasma

Outcome measures

Measure	Lipidem n=34 Participants i.v. lipid emulsion containing fractionated fish oil (n-3 fatty acid triglycerides) Lipidem: Lipoplus i.v. lipid emulsion for parenteral nutrition	Lipofundin MCT n=27 Participants i.v. lipid emulsion Lipofundin MCT 20%: Lipofundin MCT 20% i.v. lipid emulsion for parenteral nutrition
Triene:Tetraene Ratio in Plasma, Reduction From Baseline	0.011 Ratio Standard Deviation 0.024	0.008 Ratio Standard Deviation 0.028

SECONDARY outcome

Timeframe: 8 weeks

Number of adverse events (including serious adverse events)

Outcome measures

Measure	Lipidem n=38 Participants i.v. lipid emulsion containing fractionated fish oil (n-3 fatty acid triglycerides) Lipidem: Lipoplus i.v. lipid emulsion for parenteral nutrition	Lipofundin MCT n=34 Participants i.v. lipid emulsion Lipofundin MCT 20%: Lipofundin MCT 20% i.v. lipid emulsion for parenteral nutrition
Adverse Events	31 Adverse events	25 Adverse events

SECONDARY outcome

Timeframe: 8 weeks

Population: Full Analysis Set

Body mass index Change from baseline

Outcome measures

Measure	Lipidem n=36 Participants i.v. lipid emulsion containing fractionated fish oil (n-3 fatty acid triglycerides) Lipidem: Lipoplus i.v. lipid emulsion for parenteral nutrition	Lipofundin MCT n=31 Participants i.v. lipid emulsion Lipofundin MCT 20%: Lipofundin MCT 20% i.v. lipid emulsion for parenteral nutrition
BMI	0.4 kg/m^2 Standard Deviation 0.7	0.2 kg/m^2 Standard Deviation 0.7

SECONDARY outcome

Timeframe: 8 weeks

Change from baseline

Outcome measures

Measure	Lipidem n=6 Participants i.v. lipid emulsion containing fractionated fish oil (n-3 fatty acid triglycerides) Lipidem: Lipoplus i.v. lipid emulsion for parenteral nutrition	Lipofundin MCT n=3 Participants i.v. lipid emulsion Lipofundin MCT 20%: Lipofundin MCT 20% i.v. lipid emulsion for parenteral nutrition
Prothrombin Time (PT)	-0.8 s Standard Deviation 1.15	1.27 s Standard Deviation 5.16

Adverse Events

Lipidem

Serious events: 5 serious events

Other events: 15 other events

Deaths: 0 deaths

Lipofundin MCT

Serious events: 3 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Measure	Lipidem n=40 participants at risk i.v. lipid emulsion containing fractionated fish oil (n-3 fatty acid triglycerides) Lipidem: Lipoplus i.v. lipid emulsion for parenteral nutrition	Lipofundin MCT n=34 participants at risk i.v. lipid emulsion Lipofundin MCT 20%: Lipofundin MCT 20% i.v. lipid emulsion for parenteral nutrition
Infections and infestations Stoma site infection	2.5% 1/40 • Number of events 1 • 8 weeks	0.00% 0/34 • 8 weeks
Infections and infestations Device related infection	2.5% 1/40 • Number of events 1 • 8 weeks	5.9% 2/34 • Number of events 2 • 8 weeks
Blood and lymphatic system disorders Anaemia	2.5% 1/40 • Number of events 1 • 8 weeks	0.00% 0/34 • 8 weeks
Product Issues Device breakage	2.5% 1/40 • Number of events 1 • 8 weeks	0.00% 0/34 • 8 weeks
Infections and infestations Dermo-hypodermitis	2.5% 1/40 • Number of events 1 • 8 weeks	0.00% 0/34 • 8 weeks
Gastrointestinal disorders Abdominal pain	0.00% 0/40 • 8 weeks	2.9% 1/34 • Number of events 1 • 8 weeks
Product Issues Device dislocatioin	0.00% 0/40 • 8 weeks	2.9% 1/34 • Number of events 1 • 8 weeks
Gastrointestinal disorders Intestinal pseudo-obstruction	0.00% 0/40 • 8 weeks	2.9% 1/34 • Number of events 1 • 8 weeks

Other adverse events

Measure	Lipidem n=40 participants at risk i.v. lipid emulsion containing fractionated fish oil (n-3 fatty acid triglycerides) Lipidem: Lipoplus i.v. lipid emulsion for parenteral nutrition	Lipofundin MCT n=34 participants at risk i.v. lipid emulsion Lipofundin MCT 20%: Lipofundin MCT 20% i.v. lipid emulsion for parenteral nutrition
Investigations White blood cell	2.5% 1/40 • Number of events 1 • 8 weeks	0.00% 0/34 • 8 weeks
Injury, poisoning and procedural complications Overdose	2.5% 1/40 • Number of events 1 • 8 weeks	0.00% 0/34 • 8 weeks
Investigations Alanine Aminotransferase increased	7.5% 3/40 • Number of events 3 • 8 weeks	0.00% 0/34 • 8 weeks
Infections and infestations Breast abscess	2.5% 1/40 • Number of events 1 • 8 weeks	0.00% 0/34 • 8 weeks
Gastrointestinal disorders Diarrhoea	7.5% 3/40 • Number of events 3 • 8 weeks	0.00% 0/34 • 8 weeks
Gastrointestinal disorders Nausea	2.5% 1/40 • Number of events 1 • 8 weeks	0.00% 0/34 • 8 weeks
Musculoskeletal and connective tissue disorders Muscle spasms	2.5% 1/40 • Number of events 1 • 8 weeks	0.00% 0/34 • 8 weeks
Cardiac disorders Palpitations	2.5% 1/40 • Number of events 1 • 8 weeks	0.00% 0/34 • 8 weeks
Nervous system disorders Headache	2.5% 1/40 • Number of events 1 • 8 weeks	2.9% 1/34 • Number of events 1 • 8 weeks
Skin and subcutaneous tissue disorders Hyperhydrosis	2.5% 1/40 • Number of events 1 • 8 weeks	0.00% 0/34 • 8 weeks
Blood and lymphatic system disorders Anaemia	2.5% 1/40 • Number of events 2 • 8 weeks	0.00% 0/34 • 8 weeks
Metabolism and nutrition disorders Hypophosphataemia	2.5% 1/40 • Number of events 1 • 8 weeks	0.00% 0/34 • 8 weeks
General disorders Pyrexia	2.5% 1/40 • Number of events 1 • 8 weeks	0.00% 0/34 • 8 weeks
Investigations Asparte Aminotransferase increased	2.5% 1/40 • Number of events 1 • 8 weeks	0.00% 0/34 • 8 weeks
Gastrointestinal disorders Vomiting	2.5% 1/40 • Number of events 1 • 8 weeks	0.00% 0/34 • 8 weeks
Infections and infestations Tracheitis	2.5% 1/40 • Number of events 1 • 8 weeks	0.00% 0/34 • 8 weeks
Vascular disorders Hypotension	2.5% 1/40 • Number of events 1 • 8 weeks	0.00% 0/34 • 8 weeks
Immune system disorders Drug Hypersensitivity	2.5% 1/40 • Number of events 1 • 8 weeks	0.00% 0/34 • 8 weeks
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/40 • 8 weeks	2.9% 1/34 • Number of events 1 • 8 weeks
Infections and infestations Lymphangitis	0.00% 0/40 • 8 weeks	2.9% 1/34 • Number of events 1 • 8 weeks
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/40 • 8 weeks	2.9% 1/34 • Number of events 1 • 8 weeks
Nervous system disorders Paresthesia	0.00% 0/40 • 8 weeks	2.9% 1/34 • Number of events 1 • 8 weeks
General disorders Fatigue	0.00% 0/40 • 8 weeks	2.9% 1/34 • Number of events 1 • 8 weeks
Respiratory, thoracic and mediastinal disorders Dyspnoe exertional	0.00% 0/40 • 8 weeks	2.9% 1/34 • Number of events 1 • 8 weeks
Gastrointestinal disorders Intestinal pseudo-obstruction	0.00% 0/40 • 8 weeks	2.9% 1/34 • Number of events 1 • 8 weeks
Infections and infestations Influenza	0.00% 0/40 • 8 weeks	5.9% 2/34 • Number of events 2 • 8 weeks
Infections and infestations Deep vein thrombosis	0.00% 0/40 • 8 weeks	2.9% 1/34 • Number of events 1 • 8 weeks
Infections and infestations Bronchitis	0.00% 0/40 • 8 weeks	2.9% 1/34 • Number of events 1 • 8 weeks
Product Issues Device infusion issue	0.00% 0/40 • 8 weeks	2.9% 1/34 • Number of events 1 • 8 weeks
Infections and infestations Nasopharyngitis	0.00% 0/40 • 8 weeks	5.9% 2/34 • Number of events 2 • 8 weeks
Infections and infestations Laryngitis	0.00% 0/40 • 8 weeks	2.9% 1/34 • Number of events 1 • 8 weeks
Gastrointestinal disorders Flatulence	0.00% 0/40 • 8 weeks	2.9% 1/34 • Number of events 1 • 8 weeks
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/40 • 8 weeks	2.9% 1/34 • Number of events 1 • 8 weeks
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/40 • 8 weeks	2.9% 1/34 • Number of events 1 • 8 weeks
Infections and infestations Lung infection	0.00% 0/40 • 8 weeks	2.9% 1/34 • Number of events 1 • 8 weeks
Gastrointestinal disorders Abdominal pain	2.5% 1/40 • Number of events 1 • 8 weeks	0.00% 0/34 • 8 weeks
Respiratory, thoracic and mediastinal disorders Epistaxis	2.5% 1/40 • Number of events 2 • 8 weeks	0.00% 0/34 • 8 weeks

Additional Information

Study Manager

B. Braun Melsungen

Phone: 05661/71

Email: studies@bbraun.com

Results disclosure agreements

• Principal investigator is a sponsor employee In order to ensure that the Sponsor will be able to make comments and suggestions where pertinent, material for public dissemination will be submitted to the Sponsor for review at least sixty (60) days (or longer if specified elsewhere) prior to submission for publication, public dissemination, or review by a publication committee. The PI agrees that all reasonable comments made by the Sponsor in relation to a proposed publication will be incorporated into the publication.
• Publication restrictions are in place

Restriction type: OTHER