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Phenylalanine, Methionine and Histidine Requirements in TPN Fed Neonates

NCT05562310 NA RECRUITING

This is a single center project assessing the requirements for three essential amino acids in TPN fed neonates. Using the Carbon Oxidation method (indicator amino oxidation and direct amino acid oxidation method), the investigators will determine the requirement of each of the 3 amino acids. The investigators will first determine the requirement for Phenylalanine, then Methionine and finally Histidine. The investigators will recruit 18 - 20 babies per amino acid study. Breath and urine samples will be collected to determine the oxidation of the indicator amino acid. The response of the indicator amino acid to changes in intake of the test amino acid (phenylalanine, methionine, and histidine) will be analyzed by bi-phase linear mixed effect model to determine the breakpoint or mean requirement for each amino acid. It is hypothesized that the requirement for phenylalanine, methionine and histidine will be at least 50% lower than what is currently available in commercial amino acids solutions used for TPN feeding of neonates.

Details

Lead sponsorThe Hospital for Sick Children
PhaseNA
StatusRECRUITING
Enrolment60
Start dateSun Apr 02 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
CompletionThu Sep 02 2027 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

Interventions

Countries

Canada