Tralement Versus a Fixed-dose Trace Element Combination Product of Zinc, Copper, and Selenious Acid to Evaluate Product Safety in Pediatric Patients >3 to 17 Years of Age Requiring Long-term Parenteral Nutrition

Tralement versus a fixed-dose trace element combination product of zinc, copper, and selenious acid to evaluate product safety in pediatric patients >3 to 17 years of age requiring long-term parenteral nutrition.

Inclusion Criteria:Pediatric (≥3 to 17 years of age) participants weighing >10 kg with assent to participation and his/her parent or legal guardian is willing and able to sign the informed consent approved by the Institutional Review Board (IRB) or Independent Ethics Committee (IEC).Male and female participants who are new users to home parenteral nutrition as a source of trace elements when oral or enteral nutrition is not possible, insufficient, or, contraindicated.Anticipated duration of home parenteral nutrition use is 6 months or greater.A normal baseline brain MRI scan.A normal blood manganese concentration.Ability to undergo additional 2 brain MRI scans over the six-month study period (Sedation, if appropriate, to be determined by the Principal Investigator's study site, institutional review board recommendations, and parent/guardian assent).Definitive contraception for females of reproductive age.Exclusion Criteria:Prior parenteral nutrition therapy.Hypersensitivity or allergy to zinc or copper.Baseline ferritin ≥300 ng/mL or below 100 ng/mL.Baseline Transferrin Saturation (TSAT) ≥45% or below 20%.Prior or current cholestatic liver disease defined as a clinical condition associated with decrease in bile flow due to impaired secretion by hepatocytes or to obstruction of bile flow through intra-or extrahepatic bile ducts.Liver function studies with transaminases greater than two-fold normal or total bilirubin >2 mg/dL.Brain MRI exclusion criteria: MRI-unsafe metal implants, claustrophobia.Known excess environmental exposure to manganese.Less than 1-year expected survival, as anticipated by their primary provider.Current participation in another clinical trial.Females in pregnant state.