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 ω-3 FAs as a mixed emulsion containing α-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 µmol/L vs SOE group 2.3 ± 3.5 µmol/L, P < .01; 95% confidence interval [CI], -6.2 to -1.4). In plasma and red blood cell (RBC) phospholipids, the ω-3 FAs C20:5ω-3 (eicosapentaenoic acid) and + C22:6ω-3 (docosahexaenoic acid) increased significantly in the SMOFlipid group on day 29. The ω-3:ω-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 α-tocopherol concentration increased significantly more with SMOFlipid 20% (15.7 ± 15.9 vs 5.4 ± 15.2 µmol/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 ω-3 FA and α-tocopherol status without changing lipid peroxidation.
Goulet
Olivier
O
Department of Pediatric Gastroenterology, Hepatology and Nutrition, Hôpital des Enfants Malades, University of Paris 5, René Descartes, France. olivier.goulet@nck.aphp.fr
Antébi
Helena
H
Wolf
Claude
C
Talbotec
Cécile
C
Alcindor
Louis-Gérald
LG
Corriol
Odile
O
Lamor
Michèle
M
Colomb-Jung
Virginie
V
D000293:Adolescent; D001663:Bilirubin / Q000097:blood; D002648:Child; D002675:Child, Preschool; D008078:Cholesterol, LDL / Q000097:blood; D004041:Dietary Fats / Q000008:administration & dosage; D004311:Double-Blind Method; D005217:Fat Emulsions, Intravenous / Q000008:administration & dosage* / Q000009:adverse effects; D015525:Fatty Acids, Omega-3 / Q000097:blood*; D005260:Female; D005395:Fish Oils / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007223:Infant; D015227:Lipid Peroxidation; D008297:Male; D000069463:Olive Oil; D016331:Parenteral Nutrition, Home / Q000379:methods*; D010743:Phospholipids / Q000737:chemistry; D010938:Plant Oils / Q000008:administration & dosage* / Q000009:adverse effects; D013024:Soybean Oil / Q000008:administration & dosage* / Q000009:adverse effects; D017392:Thiobarbituric Acid Reactive Substances; D016896:Treatment Outcome; D014280:Triglycerides / Q000008:administration & dosage* / Q000009:adverse effects; D024502:alpha-Tocopherol / Q000097:blood / Q000494:pharmacology
D008078:Cholesterol, LDL; D004041:Dietary Fats; D005217:Fat Emulsions, Intravenous; D015525:Fatty Acids, Omega-3; D005395:Fish Oils; D000069463:Olive Oil; D010743:Phospholipids; D010938:Plant Oils; D017392:Thiobarbituric Acid Reactive Substances; D014280:Triglycerides; D013024:Soybean Oil; D024502:alpha-Tocopherol; D001663:Bilirubin