Tags

Type your tag names separated by a space and hit enter

Four-week parenteral nutrition using a third generation lipid emulsion (SMOFlipid)--a double-blind, randomised, multicentre study in adults.
Clin Nutr 2013; 32(2):224-31CN

Abstract

PRECIS

The aim of this study was to evaluate the safety and tolerance of a soybean/MCT/olive/fish oil emulsion in intestinal failure patients on long-term parenteral nutrition. 73 patients took part in a randomized, double-blind, multi-centre study. The study demonstrates that the lipid emulsion containing four different types of oils is safe and well tolerated in long-term PN.

BACKGROUND & AIM

Long-term safety and efficacy of a lipid emulsion containing soybean oil, medium-chain triglycerides (MCT), olive oil and fish oil and enriched in vitamin E have not yet been evaluated in adult patients requiring long-term parenteral nutrition (PN).

METHODS

Randomised, controlled, double-blind, multicentre study in 73 patients with stable intestinal failure, requiring PN with either soybean/MCT/olive/fish emulsion (SMOFlipid, n = 34) or soybean emulsion (Intralipid, control n = 39) for 4 weeks. Safety and tolerance were monitored with standard clinical laboratory parameters, adverse events (AEs, according to the Common Terminology Criteria for Adverse Events (CTCAE) classification v 3.0) and vital signs. Fatty acid pattern in red blood cell phospholipids and plasma lipoproteins, serum Vitamin E, Interleukin (IL)-6, and soluble tumour necrosis (s-TNF)-receptor(R)II were also evaluated.

RESULTS

Mean concentrations of alanine transaminase (ALT), aspartate transaminase (AST) and total bilirubin, whilst remaining within the reference range, were significantly lower with soybean/MCT/olive/fish (SMOF) oil emulsion after the treatment period compared to control. Eicosapentaenoic acid, docosahexaenoic acid and n-3/n-6 fatty acid ratio increased in the SMOF group, while they remained unchanged in the control in plasma and RBC. Serum α-tocopherol concentrations significantly increased in the study group compared to control (p = 0.0004). IL-6 and sTNF-RII levels did not change during the study period. Grade 4 (serious) adverse events occurred in 2 SMOF patients and in 8 control patients (p = 0.03).

CONCLUSIONS

Soybean/MCT/olive/fish emulsion was safe and well tolerated over 4 weeks and leads to positive change in fatty acids profile.

Authors+Show Affiliations

Jagiellonian University Medical College, Krakow, Poland.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

22796064

Citation

Klek, Stanislaw, et al. "Four-week Parenteral Nutrition Using a Third Generation Lipid Emulsion (SMOFlipid)--a Double-blind, Randomised, Multicentre Study in Adults." Clinical Nutrition (Edinburgh, Scotland), vol. 32, no. 2, 2013, pp. 224-31.
Klek S, Chambrier C, Singer P, et al. Four-week parenteral nutrition using a third generation lipid emulsion (SMOFlipid)--a double-blind, randomised, multicentre study in adults. Clin Nutr. 2013;32(2):224-31.
Klek, S., Chambrier, C., Singer, P., Rubin, M., Bowling, T., Staun, M., ... Shaffer, J. (2013). Four-week parenteral nutrition using a third generation lipid emulsion (SMOFlipid)--a double-blind, randomised, multicentre study in adults. Clinical Nutrition (Edinburgh, Scotland), 32(2), pp. 224-31. doi:10.1016/j.clnu.2012.06.011.
Klek S, et al. Four-week Parenteral Nutrition Using a Third Generation Lipid Emulsion (SMOFlipid)--a Double-blind, Randomised, Multicentre Study in Adults. Clin Nutr. 2013;32(2):224-31. PubMed PMID: 22796064.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Four-week parenteral nutrition using a third generation lipid emulsion (SMOFlipid)--a double-blind, randomised, multicentre study in adults. AU - Klek,Stanislaw, AU - Chambrier,Cecile, AU - Singer,Pierre, AU - Rubin,Moshe, AU - Bowling,Tim, AU - Staun,Michael, AU - Joly,Francisca, AU - Rasmussen,Henrik, AU - Strauss,Boyd J, AU - Wanten,Geert, AU - Smith,Ross, AU - Abraham,Arun, AU - Szczepanek,Kinga, AU - Shaffer,Jon, Y1 - 2012/07/12/ PY - 2011/09/12/received PY - 2012/06/12/revised PY - 2012/06/20/accepted PY - 2012/7/17/entrez PY - 2012/7/17/pubmed PY - 2013/9/24/medline SP - 224 EP - 31 JF - Clinical nutrition (Edinburgh, Scotland) JO - Clin Nutr VL - 32 IS - 2 N2 - PRECIS: The aim of this study was to evaluate the safety and tolerance of a soybean/MCT/olive/fish oil emulsion in intestinal failure patients on long-term parenteral nutrition. 73 patients took part in a randomized, double-blind, multi-centre study. The study demonstrates that the lipid emulsion containing four different types of oils is safe and well tolerated in long-term PN. BACKGROUND & AIM: Long-term safety and efficacy of a lipid emulsion containing soybean oil, medium-chain triglycerides (MCT), olive oil and fish oil and enriched in vitamin E have not yet been evaluated in adult patients requiring long-term parenteral nutrition (PN). METHODS: Randomised, controlled, double-blind, multicentre study in 73 patients with stable intestinal failure, requiring PN with either soybean/MCT/olive/fish emulsion (SMOFlipid, n = 34) or soybean emulsion (Intralipid, control n = 39) for 4 weeks. Safety and tolerance were monitored with standard clinical laboratory parameters, adverse events (AEs, according to the Common Terminology Criteria for Adverse Events (CTCAE) classification v 3.0) and vital signs. Fatty acid pattern in red blood cell phospholipids and plasma lipoproteins, serum Vitamin E, Interleukin (IL)-6, and soluble tumour necrosis (s-TNF)-receptor(R)II were also evaluated. RESULTS: Mean concentrations of alanine transaminase (ALT), aspartate transaminase (AST) and total bilirubin, whilst remaining within the reference range, were significantly lower with soybean/MCT/olive/fish (SMOF) oil emulsion after the treatment period compared to control. Eicosapentaenoic acid, docosahexaenoic acid and n-3/n-6 fatty acid ratio increased in the SMOF group, while they remained unchanged in the control in plasma and RBC. Serum α-tocopherol concentrations significantly increased in the study group compared to control (p = 0.0004). IL-6 and sTNF-RII levels did not change during the study period. Grade 4 (serious) adverse events occurred in 2 SMOF patients and in 8 control patients (p = 0.03). CONCLUSIONS: Soybean/MCT/olive/fish emulsion was safe and well tolerated over 4 weeks and leads to positive change in fatty acids profile. SN - 1532-1983 UR - https://www.unboundmedicine.com/medline/citation/22796064/Four_week_parenteral_nutrition_using_a_third_generation_lipid_emulsion__SMOFlipid___a_double_blind_randomised_multicentre_study_in_adults_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0261-5614(12)00134-3 DB - PRIME DP - Unbound Medicine ER -