Crossover Study on the Effect of Omegaven in Combination With Different Lipid Emulsions in Home Parenteral Nutrition

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-15

Study Completion Date

2016-06-30

Brief Summary

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The aim of this study was to evaluate the safety and tolerance of ClinOleic or Lipoplus or SMOFlipid lipid emulsions. After 6 weeks of each lipid emulsion, Omegaven (fish oil) was added for a further 4 weeks. The safety and tolerance was evaluated after each lipid emulsion cycle by biochemistry, hematology and coagulation variables, vital signs and adverse events. We also analysed fatty acid profiles in plasma or erythrocyte phospholipids, antioxidant enzyme activities, lipid peroxidation products, plasma lipids and pro-inflammatory cytokine production after in vitro stimulation of whole blood by lipopolysacharide in HPN patients. The non-interventional group of healthy controls was included for comparison.

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Detailed Description

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Intravenous lipid emulsions (LEs) are an indispensable part of home parenteral nutrition (HPN). All commercially obtainable LEs are applicable for HPN in providing a source of energy and essential fatty acids. The originally used soyabean oil-based LE (Intralipid) have been suspected of being associated with a higher risk of pro-inflammatory lipid-mediator production due to their high content of n-6 polyunsaturated fatty acids. The more modern mixes of soyabean oil, and/or olive oil, and/or fish oil LEs with beneficial responses compared with Intralipid are available. Given that there are no clear clinical recommendations for LE application in HPN, we performed this cross-over design, phase 4 study comparing ClinOleic, Lipoplus or SMOFlipid in chronic intestinal failure patients with additional escalation of fish oil using Omegaven.

Conditions

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Parenteral Nutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1 Home Parenteral Nutrition, Cross-over

Random Cycle Sequence - Cycle 1: Clinoleic (baseline), 50g/per day, 42 days Clinoleic + Omegaven, 40g + 10g/per day, 28 days. Cycle 2: Lipoplus (baseline), 50g/per day, 42 days Lipoplus + Omegaven, 40g + 10g/per day, 28 days. Cycle 3: SMOFlipid (baseline), 50g/per day, 42 days SMOFlipid + Omegaven, 40g + 10g/per day, 28 days.

Group Type EXPERIMENTAL

ClinOleic (baseline)

Intervention Type DRUG

Lipid emulsion in pharmacy compounded all-in-one admixture

ClinOleic + Omegaven

Intervention Type DRUG

Lipid emulsion in pharmacy compounded all-in-one admixture

Lipoplus (baseline)

Intervention Type DRUG

Lipid emulsion in pharmacy compounded all-in-one admixture

Lipoplus + Omegaven

Intervention Type DRUG

Lipid emulsion in pharmacy compounded all-in-one admixture

SMOFlipid (baseline)

Intervention Type DRUG

Lipid emulsion in pharmacy compounded all-in-one admixture

SMOFlipid + Omegaven

Intervention Type DRUG

Lipid emulsion in pharmacy compounded all-in-one admixture

2 Home Parenteral Nutrition, Cross-over

Random Cycle Sequence - Cycle 1: Clinoleic (baseline), 50g/per day, 42 days Clinoleic + Omegaven, 40g + 10g/per day, 28 days. Cycle 2: Lipoplus (baseline), 50g/per day, 42 days Lipoplus + Omegaven, 40g + 10g/per day, 28 days. Cycle 3: SMOFlipid (baseline), 50g/per day, 42 days SMOFlipid + Omegaven, 40g + 10g/per day, 28 days.

Group Type ACTIVE_COMPARATOR

ClinOleic (baseline)

Intervention Type DRUG

Lipid emulsion in pharmacy compounded all-in-one admixture

ClinOleic + Omegaven

Intervention Type DRUG

Lipid emulsion in pharmacy compounded all-in-one admixture

Lipoplus (baseline)

Intervention Type DRUG

Lipid emulsion in pharmacy compounded all-in-one admixture

Lipoplus + Omegaven

Intervention Type DRUG

Lipid emulsion in pharmacy compounded all-in-one admixture

SMOFlipid (baseline)

Intervention Type DRUG

Lipid emulsion in pharmacy compounded all-in-one admixture

SMOFlipid + Omegaven

Intervention Type DRUG

Lipid emulsion in pharmacy compounded all-in-one admixture

Comparator3

Healthy Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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ClinOleic (baseline)

Lipid emulsion in pharmacy compounded all-in-one admixture

Intervention Type DRUG

ClinOleic + Omegaven

Lipid emulsion in pharmacy compounded all-in-one admixture

Intervention Type DRUG

Lipoplus (baseline)

Lipid emulsion in pharmacy compounded all-in-one admixture

Intervention Type DRUG

Lipoplus + Omegaven

Lipid emulsion in pharmacy compounded all-in-one admixture

Intervention Type DRUG

SMOFlipid (baseline)

Lipid emulsion in pharmacy compounded all-in-one admixture

Intervention Type DRUG

SMOFlipid + Omegaven

Lipid emulsion in pharmacy compounded all-in-one admixture

Intervention Type DRUG

Other Intervention Names

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ClinOleic 20% Baxter ClinOleic 20% Baxter + Omegaven 10% Fresenius Kabi Lipoplus 20% BBraun Melsungen Lipoplus 20% BBraun Melsungen + Omegaven 10% Fresenius Kabi SMOFlipid 20% Fresenius Kabi SMOFlipid 20% Fresenius Kabi + Omegaven 10% Fresenius Kabi

Eligibility Criteria

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Inclusion Criteria

* Home parenteral nutrition patients in need of parenteral nutrition administration \> 4 days/week
* Parenteral duration expectancy \> 8 months
* Stable clinical condition without any complications in the past 2 months
* Written consent from the subject

Exclusion Criteria

* Known hypersensitivity to any of the active substances or excipients
* Unstable conditions
* Active cancer or its treatment
* Established immunodeficiency
* Advanced organ dysfunction from chronic disease

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No