Evaluation of OMEGAVEN 10%® (n-3 EFA Lipid Emulsion) in Home Parenteral Nutrition-associated Live… (NCT01284049) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of OMEGAVEN 10%® (n-3 EFA Lipid Emulsion) in Home Parenteral Nutrition-associated Liver Disease
France31 participantsStarted 2011-11
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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.
* …