Tralement Versus a Fixed-dose Trace Element Combination Product of Zinc, Copper, and Selenious Acid to Evaluate Product Safety in Adult Patients 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 adult patients requiring long-term parenteral nutrition.

Inclusion Criteria:Adult (≥18 to ≤80 years of age) participants able to provide informed consent.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).Definitive contraception for females of reproductive age.Exclusion Criteria:Prior parenteral nutrition therapy.Hypersensitivity or allergy to zinc or copper.History of occupational exposure to manganese and documented by laboratory test results.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.