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The HOME Study (HPN With OMEGA-3)

A Randomized, Controlled, Double-blind, Multicenter Clinical Trial on Home Parenteral Nutrition Using an Omega-3 Fatty Acid Enriched MCT/LCT Lipid Emulsion

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03282955
Acronym
HOME
Enrollment
74
Registered
2017-09-14
Start date
2018-01-08
Completion date
2022-07-19
Last updated
2025-07-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients Requiring Home Parenteral Nutrition

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.

Interventions

DRUGLipidem

Lipoplus i.v. lipid emulsion for parenteral nutrition

DRUGLipofundin MCT 20%

Lipofundin MCT 20% i.v. lipid emulsion for parenteral nutrition

Sponsors

B. Braun Melsungen AG
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Inclusion: * Signed informed consent available * Male or female patients ≥ 18 years of age * Patients with chronic intestinal failure receiving HPN including lipids in whom the parenteral macronutrients have not been changed by more than 10% for at least 3 months * Patients receiving ≥ 3.0 g lipids/kg body weight per week Exclusion: * Persistent high total bilirubin values in medical history of last 6 months (\> 40µmol/l) * Patients in whom PN was interrupted for longer than 4 continuous weeks in the preceding 6 months * Patients with history of cancer and anti-cancer treatment within the last 2 years * Hypersensitivity to egg, fish, peanut or soya-bean protein or to any of the active substances or excipients * Patients treated in the past or currently with Teduglutide * Contraindications to investigational products (if available from medical records) including: * Severe hyperlipidemia, including severe hypertriglyceridaemia (≥1000 mg/dl or 11.4 mmol/l) * Severe coagulopathy * Intrahepatic cholestasis * Severe hepatic insufficiency * Severe renal insufficiency in absence of renal replacement therapy * Acute thromboembolic events * Fat embolism * Aggravating haemorrhagic diatheses * Metabolic acidosis * General contraindications to parenteral nutrition (if available from medical records) including: * Unstable circulatory status with vital threat (states of collapse and shock) * Acute phase of cardiac infarction or stroke * Unstable metabolic conditions (e.g. decompensated diabetes mellitus, severe sepsis, coma of unknown origin) * Inadequate cellular oxygen supply * Disturbances of the electrolyte and fluid balance (e.g. hypokalaemia and hypotonic dehydration) * Acute pulmonary edema * Decompensated cardiac insufficiency * Positive test for HIV, Hepatitis B or C (from medical history) * Known or suspected drug or alcohol abuse * Patients who are unwilling or mentally and/or physically unable to adhere to study procedures * Participation in another interventional clinical trial in parallel or within three months prior to the start of this clinical trial * Any medical condition that in the opinion of the investigator might put the subject at risk or interfere with patients participation For women with childbearing potential (i.e. females who are not chemically or surgically sterile or females who are not post-menopausal) * Women of childbearing potential tested positive on standard pregnancy test (urine dipstick) * Lactation * Women of childbearing potential who do not agree to apply adequate contraception * Persons of legal age who are the subject of a legal protection measure or who are unable to express their consent

Design outcomes

Primary

MeasureTime frameDescription
Change of Liver Function Parameters From Baseline to Visit 28 weeksChanges 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

MeasureTime frameDescription
Alanine Transaminase (ALT)8 weeksChange from baseline
Aspartate Transaminase (AST)8 weeksChange from baseline
AST/ALT Ratio8 weeksChange from baseline
Alkaline Phosphatase (ALP)8 weeksChange from baseline
Gamma-glutamyl Transpeptidase (GGT)8 weeksChange from baseline
White Blood Cells (WBCs)8 weeksChange from baseline
Red Blood Cells (RBCs)8 weeksChange from baseline
Hemoglobin (Hb)8 weeksChange from baseline
Platelets8 weeksChange from baseline
International Normalized Ratio (INR) (if Not Possible Prothrombin Time [PT = Quick-value] is Accepted)8 weeksChange from baseline
Activated Partial Thromboplastin Time (aPTT)8 weeksChange from baseline
Hematocrit (Hct)8 weeksChange from baseline
Blood Glucose8 weeksChange from baseline
Sodium8 weeksChange from baseline
Chloride8 weeksChange from baseline
Bilirubin8 weeksChange from baseline
Calcium8 weeksChange from baseline
Magnesium8 weeksChange from baseline
Phosphate8 weeksChange from baseline
Serum Creatinine8 weeksChange from baseline
Triglycerides8 weeksChange from baseline
Cholesterol8 weeksChange from baseline
High-density Lipoprotein (HDL)8 weeksChange from baseline
Low-density Lipoprotein (LDL)8 weeksChange from baseline
C-reactive Protein (CRP)8 weeksChange from baseline
α-Tocopherol/Vitamin E (Facultative if Routinely Assessed)8 weeksChange from baseline
Triene:Tetraene Ratio in Plasma, Reduction From Baseline8 weeksDerived from fatty acid pattern in plasma
Adverse Events8 weeksNumber of adverse events (including serious adverse events)
BMI8 weeksBody mass index Change from baseline
Prothrombin Time (PT)8 weeksChange from baseline
Potassium8 weeksChange from baseline

Countries

France, Italy, Netherlands, Poland, United Kingdom

Participant flow

Participants by arm

ArmCount
Lipidem
i.v. lipid emulsion containing fractionated fish oil (n-3 fatty acid triglycerides) Lipidem: Lipoplus i.v. lipid emulsion for parenteral nutrition
38
Lipofundin MCT
i.v. lipid emulsion Lipofundin MCT 20%: Lipofundin MCT 20% i.v. lipid emulsion for parenteral nutrition
34
Total72

Baseline characteristics

CharacteristicLipofundin MCTTotalLipidem
Age, Continuous52.44 years
STANDARD_DEVIATION 15.5
51.22 years
STANDARD_DEVIATION 15.6
50.13 years
STANDARD_DEVIATION 15.82
Race/Ethnicity, Customized
Black or African American
0 Participants1 Participants1 Participants
Race/Ethnicity, Customized
Missing
2 Participants4 Participants2 Participants
Race/Ethnicity, Customized
Native Hawaiian/Other Pacific
1 Participants1 Participants0 Participants
Race/Ethnicity, Customized
White
31 Participants66 Participants35 Participants
Region of Enrollment
France
11 participants21 participants10 participants
Region of Enrollment
Italy
3 participants5 participants2 participants
Region of Enrollment
Netherlands
3 participants7 participants4 participants
Region of Enrollment
Poland
16 participants36 participants20 participants
Region of Enrollment
United Kingdom
1 participants3 participants2 participants
Sex: Female, Male
Female
24 Participants40 Participants16 Participants
Sex: Female, Male
Male
10 Participants32 Participants22 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 400 / 34
other
Total, other adverse events
15 / 4012 / 34
serious
Total, serious adverse events
5 / 403 / 34

Outcome results

Primary

Change of Liver Function Parameters From Baseline to Visit 2

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.

Time frame: 8 weeks

Population: Full Analysis Set

ArmMeasureValue (MEAN)Dispersion
LipidemChange of Liver Function Parameters From Baseline to Visit 20.0606 normalized sum- no unitStandard Deviation 3.0876
Lipofundin MCTChange of Liver Function Parameters From Baseline to Visit 2-0.0703 normalized sum- no unitStandard Deviation 1.8063
p-value: 0.025t-test, 1 sided
Secondary

Activated Partial Thromboplastin Time (aPTT)

Change from baseline

Time frame: 8 weeks

ArmMeasureValue (MEAN)Dispersion
LipidemActivated Partial Thromboplastin Time (aPTT)0.02 secondsStandard Deviation 3.85
Lipofundin MCTActivated Partial Thromboplastin Time (aPTT)0.97 secondsStandard Deviation 7.69
Secondary

Adverse Events

Number of adverse events (including serious adverse events)

Time frame: 8 weeks

ArmMeasureValue (NUMBER)
LipidemAdverse Events31 Adverse events
Lipofundin MCTAdverse Events25 Adverse events
Secondary

Alanine Transaminase (ALT)

Change from baseline

Time frame: 8 weeks

ArmMeasureValue (MEAN)Dispersion
LipidemAlanine Transaminase (ALT)0.06 µkat/LStandard Deviation 0.6
Lipofundin MCTAlanine Transaminase (ALT)0.01 µkat/LStandard Deviation 0.25
Secondary

Alkaline Phosphatase (ALP)

Change from baseline

Time frame: 8 weeks

ArmMeasureValue (MEAN)Dispersion
LipidemAlkaline Phosphatase (ALP)0.13 µkat/LStandard Deviation 0.66
Lipofundin MCTAlkaline Phosphatase (ALP)-0.15 µkat/LStandard Deviation 1.46
Secondary

Aspartate Transaminase (AST)

Change from baseline

Time frame: 8 weeks

ArmMeasureValue (MEAN)Dispersion
LipidemAspartate Transaminase (AST)-0.03 µkat/LStandard Deviation 0.38
Lipofundin MCTAspartate Transaminase (AST)-0.00 µkat/LStandard Deviation 0.21
Secondary

AST/ALT Ratio

Change from baseline

Time frame: 8 weeks

ArmMeasureValue (MEAN)Dispersion
LipidemAST/ALT Ratio0.53 RatioStandard Deviation 1
Lipofundin MCTAST/ALT Ratio0.89 RatioStandard Deviation 2.52
Secondary

Bilirubin

Change from baseline

Time frame: 8 weeks

ArmMeasureValue (MEAN)Dispersion
LipidemBilirubin0.36 µmol/LStandard Deviation 3.34
Lipofundin MCTBilirubin0.04 µmol/LStandard Deviation 3.26
Secondary

Blood Glucose

Change from baseline

Time frame: 8 weeks

ArmMeasureValue (MEAN)Dispersion
LipidemBlood Glucose0.43 mmol/LStandard Deviation 0.94
Lipofundin MCTBlood Glucose-0.14 mmol/LStandard Deviation 1.33
Secondary

BMI

Body mass index Change from baseline

Time frame: 8 weeks

Population: Full Analysis Set

ArmMeasureValue (MEAN)Dispersion
LipidemBMI0.4 kg/m^2Standard Deviation 0.7
Lipofundin MCTBMI0.2 kg/m^2Standard Deviation 0.7
Secondary

Calcium

Change from baseline

Time frame: 8 weeks

ArmMeasureValue (MEAN)Dispersion
LipidemCalcium-0.01 mmol/LStandard Deviation 0.15
Lipofundin MCTCalcium-0.01 mmol/LStandard Deviation 0.1
Secondary

Chloride

Change from baseline

Time frame: 8 weeks

ArmMeasureValue (MEAN)Dispersion
LipidemChloride-0.19 mmol/LStandard Deviation 3.33
Lipofundin MCTChloride-0.15 mmol/LStandard Deviation 4.08
Secondary

Cholesterol

Change from baseline

Time frame: 8 weeks

ArmMeasureValue (MEAN)Dispersion
LipidemCholesterol0.01 mmol/LStandard Deviation 0.39
Lipofundin MCTCholesterol0.02 mmol/LStandard Deviation 0.71
Secondary

C-reactive Protein (CRP)

Change from baseline

Time frame: 8 weeks

ArmMeasureValue (MEAN)Dispersion
LipidemC-reactive Protein (CRP)37.16 nmol/LStandard Deviation 160.03
Lipofundin MCTC-reactive Protein (CRP)-24.65 nmol/LStandard Deviation 209.18
Secondary

Gamma-glutamyl Transpeptidase (GGT)

Change from baseline

Time frame: 8 weeks

Population: Safety Set

ArmMeasureValue (MEAN)Dispersion
LipidemGamma-glutamyl Transpeptidase (GGT)0.02 µkat/LStandard Deviation 0.38
Lipofundin MCTGamma-glutamyl Transpeptidase (GGT)-0.11 µkat/LStandard Deviation 1.64
Secondary

Hematocrit (Hct)

Change from baseline

Time frame: 8 weeks

ArmMeasureValue (MEAN)Dispersion
LipidemHematocrit (Hct)-0.00 L/LStandard Deviation 0.03
Lipofundin MCTHematocrit (Hct)-0.01 L/LStandard Deviation 0.03
Secondary

Hemoglobin (Hb)

Change from baseline

Time frame: 8 weeks

ArmMeasureValue (MEAN)Dispersion
LipidemHemoglobin (Hb)0.52 g/LStandard Error 8.82
Lipofundin MCTHemoglobin (Hb)-1.75 g/LStandard Error 8.22
Secondary

High-density Lipoprotein (HDL)

Change from baseline

Time frame: 8 weeks

ArmMeasureValue (MEAN)Dispersion
LipidemHigh-density Lipoprotein (HDL)-0.12 mmol/LStandard Deviation 0.19
Lipofundin MCTHigh-density Lipoprotein (HDL)0.03 mmol/LStandard Deviation 0.23
Secondary

International Normalized Ratio (INR) (if Not Possible Prothrombin Time [PT = Quick-value] is Accepted)

Change from baseline

Time frame: 8 weeks

ArmMeasureValue (MEAN)Dispersion
LipidemInternational Normalized Ratio (INR) (if Not Possible Prothrombin Time [PT = Quick-value] is Accepted)-0.01 RatioStandard Deviation 0.25
Lipofundin MCTInternational Normalized Ratio (INR) (if Not Possible Prothrombin Time [PT = Quick-value] is Accepted)-0.16 RatioStandard Deviation 0.71
Secondary

Low-density Lipoprotein (LDL)

Change from baseline

Time frame: 8 weeks

ArmMeasureValue (MEAN)Dispersion
LipidemLow-density Lipoprotein (LDL)0.07 mmol/LStandard Deviation 0.33
Lipofundin MCTLow-density Lipoprotein (LDL)-0.08 mmol/LStandard Deviation 0.76
Secondary

Magnesium

Change from baseline

Time frame: 8 weeks

ArmMeasureValue (MEAN)Dispersion
LipidemMagnesium0.00 mmol/LStandard Deviation 0.09
Lipofundin MCTMagnesium-0.00 mmol/LStandard Deviation 0.06
Secondary

Phosphate

Change from baseline

Time frame: 8 weeks

ArmMeasureValue (MEAN)Dispersion
LipidemPhosphate-0.02 mmol/LStandard Deviation 0.18
Lipofundin MCTPhosphate-0.00 mmol/LStandard Deviation 0.16
Secondary

Platelets

Change from baseline

Time frame: 8 weeks

ArmMeasureValue (MEAN)Dispersion
LipidemPlatelets3.06 10^9 cells/LStandard Deviation 41.11
Lipofundin MCTPlatelets6.90 10^9 cells/LStandard Deviation 50.33
Secondary

Potassium

Change from baseline

Time frame: 8 weeks

ArmMeasureValue (MEAN)Dispersion
LipidemPotassium0.06 mmol/LStandard Deviation 0.37
Lipofundin MCTPotassium0.01 mmol/LStandard Deviation 0.46
Secondary

Prothrombin Time (PT)

Change from baseline

Time frame: 8 weeks

ArmMeasureValue (MEAN)Dispersion
LipidemProthrombin Time (PT)-0.8 sStandard Deviation 1.15
Lipofundin MCTProthrombin Time (PT)1.27 sStandard Deviation 5.16
Secondary

Red Blood Cells (RBCs)

Change from baseline

Time frame: 8 weeks

ArmMeasureValue (MEAN)Dispersion
LipidemRed Blood Cells (RBCs)-0.02 10^12 cells/LStandard Deviation 0.28
Lipofundin MCTRed Blood Cells (RBCs)-0.10 10^12 cells/LStandard Deviation 0.28
Secondary

Serum Creatinine

Change from baseline

Time frame: 8 weeks

ArmMeasureValue (MEAN)Dispersion
LipidemSerum Creatinine3.87 µmol/LStandard Deviation 32.42
Lipofundin MCTSerum Creatinine0.43 µmol/LStandard Deviation 9.23
Secondary

Sodium

Change from baseline

Time frame: 8 weeks

ArmMeasureValue (MEAN)Dispersion
LipidemSodium0.18 mmol/LStandard Deviation 2.67
Lipofundin MCTSodium-0.58 mmol/LStandard Deviation 2.74
Secondary

Triene:Tetraene Ratio in Plasma, Reduction From Baseline

Derived from fatty acid pattern in plasma

Time frame: 8 weeks

ArmMeasureValue (MEAN)Dispersion
LipidemTriene:Tetraene Ratio in Plasma, Reduction From Baseline0.011 RatioStandard Deviation 0.024
Lipofundin MCTTriene:Tetraene Ratio in Plasma, Reduction From Baseline0.008 RatioStandard Deviation 0.028
Secondary

Triglycerides

Change from baseline

Time frame: 8 weeks

ArmMeasureValue (MEAN)Dispersion
LipidemTriglycerides0.10 mmol/LStandard Deviation 0.55
Lipofundin MCTTriglycerides0.19 mmol/LStandard Deviation 0.68
Secondary

White Blood Cells (WBCs)

Change from baseline

Time frame: 8 weeks

ArmMeasureValue (MEAN)Dispersion
LipidemWhite Blood Cells (WBCs)0.45 10^9 cells/LStandard Deviation 1.42
Lipofundin MCTWhite Blood Cells (WBCs)0.19 10^9 cells/LStandard Deviation 1.39
Secondary

α-Tocopherol/Vitamin E (Facultative if Routinely Assessed)

Change from baseline

Time frame: 8 weeks

ArmMeasureValue (MEAN)Dispersion
Lipidemα-Tocopherol/Vitamin E (Facultative if Routinely Assessed)-3.00 µmol/L]Standard Deviation 6.6
Lipofundin MCTα-Tocopherol/Vitamin E (Facultative if Routinely Assessed)-1.94 µmol/L]Standard Deviation 10.99

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026