Efficacy of a long-term home parenteral nutrition regimen containing fish oil-derived n-3 polyunsaturated fatty acids: a single-centre, randomized, double blind study

BackgroundData on the use of lipid emulsions containing fish-oil (FO) derived n-3 polyunsaturated fatty acids (n-3 PUFAs) in addition to medium- and long-chain triglycerides (MCT/LCT) for long-term home parenteral nutrition (HPN) are limited. This study aimed to compare HPN regimens containing either MCT/LCT/FO-derived n-3 PUFAs (test group) or MCT/LCT (control group) with respect to efficacy and safety during 8weeks of HPN using a non-inferiority trial design with change of body mass index (BMI) as primary endpoint.MethodsThis prospective, randomized, double-blind study was conducted at the Charite, Berlin, Germany, from 02/2008 until 01/2014. Adult patients (n=42; aged 18 to 80years) requiring HPN for at least 8weeks were randomly assigned to the test or control group. Assessments included weight, height, physical examination (cardiovascular system, abdomen, respiratory tract, liver, spleen, kidney, urine tract, skin, mucous membrane, neurology, psyche, musculoskeletal system, lymph nodes), bio impedance analysis, calorimetry, blood samplings (haematology, biochemistry, fatty acid analysis) and quality of life questionnaire.ResultsBMI increased in both groups with 8weeks of HPN (BMI(test group)=1.31.1kg/m(2); BMI(control group)=0.60.9kg/m(2)) demonstrating non-inferiority of the test regimen regarding nutritional efficacy. Assessment of secondary efficacy endpoints revealed that after 8weeks of HPN with the test regimen, the proportion of n-3 PUFAs in serum, platelet and red blood cell phospholipids significantly increased, while the proportion of n-6 PUFAs decreased. The fatty acid pattern in the control group remained mostly stable. No statistically significant differences were detected between groups regarding inflammatory markers or quality of life. Laboratory parameters reflecting the safety endpoints liver function, bone metabolism, renal function, metabolic activity, lipid metabolism, coagulation and haematology were stable in both groups and no group differences were detected regarding (serious) adverse events.Conclusions The HPN regimen prepared with MCT/LCT/FO-derived n-3 PUFAs was at least as efficient in maintaining or even improving nutritional status during HPN as the control MCT/LCT regimen. Administration of FO-derived n-3 PUFAs for 8weeks altered the fatty acid pattern of serum, platelet and red blood cell phospholipids. Both regimens were safe and well tolerated.Trial registration www.clinicaltrials.gov, registration number: NCT00530738.