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Phenylalanine, Methionine and Histidine Requirements in TPN Fed Neonates

NCT05562310 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-05-30

No results posted yet for this study

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.

Conditions

  • Stable Neonates
  • Receiving Total Parenteral Nutrition (TPN)

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.

Sponsors & Collaborators

  • The Hospital for Sick Children

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Day
Max Age
28 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-02
Primary Completion
2026-09-02
Completion
2027-09-02

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05562310 on ClinicalTrials.gov