Optimizing Vitamin and Trace Element Profiles in Blood after Gastrointestinal Tract Surgery by a New Parenteral Nutrition Formula

Annals of Nutrition & Metabolism
Kazuhiko FukatsuMitsuo Nakayama

Abstract

Though micronutrient formulations for parenteral nutrition (PN) have been revised, the impacts of these changes on nutritional parameters, blood micronutrient levels, and safety have yet to be clarified. We examined the efficacy and safety of a new PN formulation with a micronutrient composition based on the Food and Drug Administration 2000 recommendation in surgical patients. This phase III clinical trial (JapicCTI-No. 142610) was a prospective, randomized, controlled, parallel-group, open-label, multicenter study. Two types of PN, OPF-108 (revised formula, n = 51) and ELN (previous formula mainly based on American Medical Association 1975 guidelines, n = 59), were given to patients from POD1 or 2 to POD7 after surgery. OPF-108 contains more vitamin B1, B6, C, and folic acid, a much lower dose of vitamin K, and less iron than ELN. Nutritional parameters and micronutrient profiles in blood and safety were evaluated. Nutritional parameters on POD5 and 8 were similar between the 2 groups. Blood vitamin B1, B6, and folic acid levels on POD 5 and 8 were higher in the OPF-108 group than in the ELN group. Only OPF-108 restored vitamin C levels to within the normal range on POD5 and 8. Vitamin K levels far exceeded the upper limit of...Continue Reading

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