A New Intravenous Fat Emulsion Containing Soybean Oil, Medium-Chain Triglycerides, Olive Oil, and Fish Oil: A Single-Center, Double-Blind Randomized Study on Efficacy and Safety in Pediatric Patients Receiving Home Parenteral Nutrition

Background: SMOFlipid 20% is an intravenous lipid emulsion (ILE) containing soybean oil, medium-chain triglycerides, olive oil, and fish oil developed to provide energy, essential fatty acids (FAs), and long-chain omega-3 FAs as a mixed emulsion containing a-tocopherol. The aim was to assess the efficacy and safety of this new ILE in pediatric patients receiving home parenteral nutrition (HPN) compared with soybean oil emulsion (SOE). Methods: This single-center, randomized, double-blind study included 28 children on HPN allocated to receive either SMOFlipid 20% (n = 15) or a standard SOE (Intralipid 20%, n = 13). ILE was administered 4 to 5 times per week (goal dose, 2.0 g/kg/d) within a parenteral nutrition regimen. Assessments, including safety and efficacy parameters, were performed on day 0 and after the last study infusion (day 29). Lipid peroxidation was determined by measurement of thiobarbituric acid reactive substances (TBARS). Results: There were no significant differences in laboratory safety parameters, including liver enzymes, between the groups on day 29. The mean +/- standard deviation changes in the total bilirubin concentration between the initial and final values (day 29 to day 0) were significantly different between groups: SMOFlipid group -1.5 +/- 2.4 mu mol/L vs SOE group 2.3 +/- 3.5 mu mol/L, P<.01; 95% confidence interval [CI], -6.2 to -1.4). In plasma and red blood cell (RBC) phospholipids, the w-3 FAs C20: 5 omega-3 (eicosapentaenoic acid) and + C22: 6 omega-3 (docosahexaenoic acid) increased significantly in the SMOFlipid group on day 29. The omega-3:omega-6 FA ratio was significantly elevated with SMOFlipid 20% compared with SOE group (plasma, day 29: 0.15 +/- 0.06 vs 0.07 +/- 0.02, P<.01, 95% CI, 0.04-0.11; and RBC, day 29: 0.23 +/- 0.07 vs 0.14 +/- 0.04, P<.01, 95% CI, 0.04-0.13). Plasma alpha-tocopherol concentration increased significantly more with SMOFlipid 20% (15.7 +/- 15.9 vs 5.4 +/- 15.2 mu mol/L, P<.05; 95% CI, -2.1 to 22.6). The low-density lipoprotein-TBARS concentrations were not significantly different between both groups, indicating that lipid peroxidation did not differ between groups. Conclusions: SMOFlipid 20%, which contains 15% fish oil, was safe and well tolerated, decreased plasma bilirubin, and increased w-3 FA and a-tocopherol status without changing lipid peroxidation. (JPEN J Parenter Enteral Nutr. 2010; 34: 485-495)