Pediatric Intestinal Failure-Associated Liver Disease Is Reversed With 6 Months of Intravenous Fish Oil

Background: Studies have suggested that when intravenous (IV) soybean oil (SO) is replaced with fish oil (FO), direct hyperbilirubinemia is more likely to resolve. The necessary duration of FO has not been established. This study seeks to determine if 24 weeks of FO is an effective and safe therapy for intestinal failure-associated liver disease (IFALD). Materials and Methods: This is a clinical trial using patients with IFALD between the ages of 2 weeks and 18 years. SO was replaced with FO (1 g/kg/d) in 10 patients who were receiving most of their calories from parenteral nutrition (PN). Patients were compared with 20 historic controls receiving SO. SO for both groups was prescribed by the primary medical team at variable doses. The primary outcome was time to reversal of cholestasis. Secondary outcomes were death, transplant, and full enteral feeds. Safety measurements included growth, essential fatty acid deficiency, and laboratory markers to assess bleeding risk. Results: The Kaplan-Meier method estimated that 75% in the FO group would experience resolution of cholestasis by 17 weeks vs 6% in the SO group (P <.0001). When compared with the SO group, the FO group had decreased serum direct bilirubin concentrations at weeks 8 (P =.03) and 12, 16, 20, and 24 weeks (P <.0001). Although length z score at the end of the study increased in the FO group compared with baseline (P =.03), there were no significant differences in other outcomes. Conclusions: A limited duration of FO appears to be safe and effective in reversing IFALD.