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
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||Phase|
|Liver Diseases||Drug: Intralipid 20%® Drug: OMEGAVEN 10%®||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Actual Primary Completion Date :||April 2015|
|Actual Study Completion Date :||March 2016|
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
- 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.
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|
|Principal Investigator:||Dr Francisca JOLY||Assistance Publique - Hôpitaux de Paris|