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

General University Hospital, Prague

Status and phase

Completed

Phase 4

Conditions

Parenteral Nutrition

Treatments

Drug: Lipoplus + Omegaven

Drug: ClinOleic (baseline)

Drug: ClinOleic + Omegaven

Drug: SMOFlipid + Omegaven

Drug: SMOFlipid (baseline)

Drug: Lipoplus (baseline)

Study type

Interventional

Funder types

Other

Identifiers

NCT03149653

NT13236-4/2012

Details and patient eligibility

About

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.

Full description

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.

Enrollment

24 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

24 participants in 3 patient groups

1 Home Parenteral Nutrition, Cross-over

Experimental group

Description:

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.

Treatment:

Drug: Lipoplus (baseline)

Drug: SMOFlipid + Omegaven

Drug: SMOFlipid (baseline)

Drug: ClinOleic + Omegaven

Drug: ClinOleic (baseline)

Drug: Lipoplus + Omegaven

2 Home Parenteral Nutrition, Cross-over

Active Comparator group

Description:

Treatment:

Drug: Lipoplus (baseline)