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

Summary

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.

Conditions

• Parenteral Nutrition

Interventions

DRUG

ClinOleic (baseline)

Lipid emulsion in pharmacy compounded all-in-one admixture

DRUG

ClinOleic + Omegaven

Lipid emulsion in pharmacy compounded all-in-one admixture

DRUG

Lipoplus (baseline)

Lipid emulsion in pharmacy compounded all-in-one admixture

DRUG

Lipoplus + Omegaven

Lipid emulsion in pharmacy compounded all-in-one admixture

DRUG

SMOFlipid (baseline)

Lipid emulsion in pharmacy compounded all-in-one admixture

DRUG

SMOFlipid + Omegaven

Lipid emulsion in pharmacy compounded all-in-one admixture

Sponsors & Collaborators

• Charles University, Czech Republic

  collaborator OTHER

• Ministry of Health, Czech Republic

  collaborator OTHER_GOV

• General University Hospital, Prague

  lead OTHER

Principal Investigators

• Frantisek Novak, MD, PhD · General University Hospital, Prague

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-01-15

Primary Completion

2016-01-07

Completion

2016-06-30

Countries

• Czechia

Study Locations