Essential fatty acid deficiency, olive oil-based intravenous lipid emulsion, and genetic polymorphisms: A pediatric randomized controlled trial

Objectives: There is a concern that decreasing soybean oil (SO) content in intravenous lipid emulsions (ILEs) may increase the risk for essential fatty acid deficiency (EFAD). This study evaluates the risk of EFAD in pediatric patients who were expected to require parenteral nutrition for at least 7 days with an 80% olive oil/20% SO ILE (OO/SO group) versus a 100% SO ILE (SO group). Methods: This randomized, double-blind, controlled, multicenter study evaluated 101 pediatric patients including 94 preterm infants. The primary outcome was the incidence of EFAD, including the analysis of the plasma fatty acid (FA) profiles and genetic polymorphism in the FA desaturase genes in patients with extreme arachidonic acid values. Results: Treatment duration was 10.3 ± 7.8 and 11.3 ± 9.4 days in the OO/SO and SO groups respectively. No EFAD was observed. Linoleic acid values increased in both groups but to a lesser extent in the OO/SO group. Arachidonic acid values remained stable within the two groups. The changes in mead acid value were opposite in the two groups, demonstrating an increase in the OO/SO group and a decrease in the SO group, leading to similar changes in the triene:tetraene ratio (T:T). Genetic polymorphisms were frequently observed in patients presenting extreme arachidonic acid values in both groups. Conclusions: The use of an 80% OO/20% SO ILE is well tolerated, safe, and does not increase the risk of EFAD in pediatric patients. The assessment of EFAD should not only consider the T:T but also the complete FA profile and genetic polymorphisms. Trial Identification Number: Trial Identification Number and URL: NCT04555044, https://clinicaltrials.gov/study/NCT04555044?term=NCT04555044&rank=1.