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Evaluation of OMEGAVEN 10%® (n-3 EFA Lipid Emulsion) in Home Parenteral Nutrition-associated Liver Disease (MEGANORM)

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ClinicalTrials.gov Identifier: NCT01284049
Recruitment Status : Completed
First Posted : January 26, 2011
Last Update Posted : March 30, 2016
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:

The objective of the study is to show that substitution of the usual lipid emulsion (Intralipid 20%®) at a dose between 0.5 and 1.0 g/kg/infusion of parenteral nutrition (n-6:n-3 ratio = 7:1) by an equivalent dose of 0.5 to 1 g/kg/infusion of another lipid emulsion, OMEGAVEN 10%® very rich in omega-3 (n-3) (n-6:n-3 ratio = 1:7) induces regression of PNALD due to the anti-inflammatory and anti-fibrotic effects of n-3 EFA.

Regression of liver disease will be defined by normalization of the five liver function tests (LFT): conjugated bilirubin, gamma GT, alkaline phosphatase, AST and ALT transaminases.

Condition or disease Intervention/treatment
Liver Diseases Drug: Intralipid 20%® Drug: OMEGAVEN 10%®

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Study in Adults on HPN Who Have Developed PNALD Comparing Equivalent Doses of Two Lipid Emulsions: OMEGAVEN 10%®, Enriched in n-3 EFA, and a Standard Lipid Emulsion, Intralipid 20%® Not Enriched in n-3 EFA + Vitamin E Supplement
Study Start Date : November 2011
Primary Completion Date : April 2015
Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Intralipid 20%®
reference treatment by standard lipid emulsion not enriched in n-3 EFA (Intralipid 20%®)+ vitamin E.
Drug: Intralipid 20%®
Administration of Intralipid 20%® at a dose ranging between 0.5 and 1 g/kg/infusion during 12 weeks.
Other Name: Arm 1
Experimental: OMEGAVEN 10%®
Interventional treatment by a lipid emulsion enriched in n-3 EFA (OMEGAVEN 10%®).
Drug: OMEGAVEN 10%®
OMEGAVEN 10%® will be used as the sole lipid supplement at a dose of 0.5 to 1.0 g/kg/Infusion with a maximum dose per infusion of 40 grams, in view of formulation constraints during 12 weeks.
Other Name: Arm 2

Primary Outcome Measures :
  1. The five liver function tests (LFT) [ Time Frame: 18 weeks after inclusion ]
    Regression of liver disease will be defined by normalization of the five liver function tests (LFT): conjugated bilirubin, gamma GT, alkaline phosphatase, AST and ALT transaminases.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age greater than or equal to 18 years.
  • Patients on HPN for chronic benign intestinal failure:

with a degree of HPN dependence ≥ two cycles of PN per week with at least one ternary infusion (comprising lipids) per week with a maximum lipid intake of 40 grams per ternary infusion

  • Expected duration of HPN dependence greater than 18 weeks at the time of inclusion.
  • Receiving HPN for at least 12 weeks in one of the three study centres, which is a sufficient period to allow resolution of any drug-induced or septic cholestasis and cytolysis related to a previous hospitalisation.
  • Presence of PNALD, defined by an abnormality of at least two of the five liver function tests performed (conjugated bilirubin, gamma glutamyltransferase, alkaline phosphatase, AST, ALT).
  • Stable patient with no infection during the six weeks preceding inclusion.
  • Medical examination performed before inclusion.
  • Written informed consent.
  • Covered by French national health insurance.

Exclusion Criteria:

  • Active cancer, regardless of the primary site.
  • Uncontrolled cardiopulmonary insufficiency.
  • Decompensated cirrhosis.
  • Severe renal failure.
  • Uncontrolled diabetes or endocrinopathy.
  • Hyperlipoproteinaemia and hypertriglyceridaemia (≥ 3 mmol/L).
  • Other causes of liver disease (biliary obstruction, alcohol, hepatitis B virus, hepatitis C virus, CMV, hepatotoxic drugs).
  • Systemic corticosteroid therapy or biotherapy (anti-TNF).
  • Pregnant women or nursing mothers.
  • Inclusion in another study terminated or less than three months.
  • Known allergy to fish or egg proteins.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01284049

Dr Francisca JOLY
Clichy, Hauts de Seine, France, 92110
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Principal Investigator: Dr Francisca JOLY Assistance Publique - Hôpitaux de Paris

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01284049     History of Changes
Other Study ID Numbers: P081231
2010-022893-15 ( EudraCT Number )
First Posted: January 26, 2011    Key Record Dates
Last Update Posted: March 30, 2016
Last Verified: March 2016

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Home Parenteral Nutrition
Intralipid 20%®
Liver diseases

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases
Vitamin E
Soybean oil, phospholipid emulsion
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Growth Substances
Fat Emulsions, Intravenous
Parenteral Nutrition Solutions
Pharmaceutical Solutions