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
Goulet O, Antébi H, Wolf C, Talbotec C, Alcindor LG, Corriol O, Lamor M, Colomb-Jung V
JPEN. Journal of parenteral and enteral nutrition · 145 citas
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Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación no declarada
Publicación
- Publicado
- 2010-09-01 · JPEN J Parenter Enteral Nutr · vol. 34 · número 5 · págs. 485–495
- Editorial
- Wiley
- Citado
- 235 citas · más que el 99% de estudios similares · 14.5× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 75 trabajos
- Acceso
- De pago
- Áreas de investigación
- Clinical Nutrition and Gastroenterology · Neonatal Respiratory Health Research · Enhanced Recovery After Surgery
- Palabras clave
- Docosahexaenoic acid, Fish oil, Eicosapentaenoic acid, Soybean oil, TBARS, Parenteral nutrition, Oleic acid, Medicine, Chemistry, Triglyceride, Fatty acid, Lipid peroxidation, Animal science, Food science, Biochemistry, Polyunsaturated fatty acid, Internal medicine, Biology, Antioxidant, Cholesterol, Fish <Actinopterygii>, Fishery
- MeSH
- humans, thiobarbituric acid reactive substances, bilirubin, dietary fats, fatty acids, omega-3, soybean oil, fat emulsions, intravenous, triglycerides, phospholipids, fish oils, plant oils, alpha-tocopherol, treatment outcome, parenteral nutrition, home, double-blind method, lipid peroxidation, adolescent, child, child, preschool, infant, female, male, cholesterol, ldl, olive oil
8 autores
- Olivier Goulet🇫🇷 · autor de correspondenciaUniversité Paris Cité; Hôpital des Enfants
- H. Antébi🇫🇷Hôpitaux Universitaires Paris-Ouest
- Claude Wolf🇫🇷Hôpital Saint-Antoine
- Cécile Talbotec🇫🇷Université Paris Cité; Hôpital des Enfants
- Louis‐Gérald Alcindor🇫🇷Hôpitaux Universitaires Paris-Ouest
- Odile Corriol🇫🇷Université Paris Cité; Hôpital des Enfants
- Michèle Lamor🇫🇷Université Paris Cité; Hôpital des Enfants
- Virginie Colomb-Jung🇫🇷Université Paris Cité; Hôpital des Enfants
Resumen
El texto original del estudio, en el idioma en que se publicó.
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.
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