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Study identifier: NCT05562310 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Phenylalanine, Methionine and Histidine Requirements in TPN Fed Neonates

Condition: Stable Neonates · Receiving Total Parenteral Nutrition (TPN)  ·  Sponsor: The Hospital for Sick Children

PhaseNA
Planned participants60
Who can joinAll sexes, 1 Day to 28 Days
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Glenda Courtney-Martin  ·  4168135744  ·  glenda.courtney-martin@sickkids.ca

Mahroukh Rafii  ·  6472151201  ·  mahroukh.rafii@sickkids.ca

Always discuss trial participation with your own doctor first.

Locations (1)

Glenda Courtney-MartinToronto, Ontario, CanadaRecruiting

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Source record: clinicaltrials.gov/study/NCT05562310