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RECRUITING
NCT05562310
NA

Phenylalanine, Methionine and Histidine Requirements in TPN Fed Neonates

Sponsor: The Hospital for Sick Children

View on ClinicalTrials.gov

Summary

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.

Official title: Phenylalanine, Methionine and Histidine Requirements in Total Parenteral Nutrition (TPN) Fed Neonates

Key Details

Gender

All

Age Range

1 Day - 28 Days

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2023-04-02

Completion Date

2027-09-02

Last Updated

2025-05-30

Healthy Volunteers

No

Interventions

DRUG

Total parenteral nutrition (TPN). This is total nutrition provided by central vein.

phenylalanine, methionine and histidine intakes will be varied in the TPN solutions to study the requirements for each of these amino acids in neonates that are TPN fed.

Locations (1)

Glenda Courtney-Martin

Toronto, Ontario, Canada