MedTrace Logo

A Physiological Study to Determine the Enteral Threonine Requirements in Infants Aged 1 to 6 Months

NCT02364843 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2024-04-18

No results posted yet for this study

Summary

This is the 5th in a series of physiological studies to determine the amino acid requirements of infants. There have been 4 studies to determine tyrosine, methionine, threonine and lysine requirements in infants when they are fed by parenterally (intravenously). Due to the new requirements of Health Canada for preparation of parenteral solutions, the investigators are starting the phase of the study that determines the enteral (oral) intake of threonine in 1 - 6 mo infants in the interim.

Conditions

  • Surgical Infants on NG/NJ/J/G-tube Feeds
  • Tracheoesophageal Fistula
  • Pierre-Robin Syndrome
  • Diaphragmatic Hernia

Interventions

DIETARY_SUPPLEMENT

Amino Acid: Threonine

Each of the 18 infants will have a different intake of dietary amino acid threonine for a 24 period and by cross-over regression analysis a break-point or requirement will be established

Sponsors & Collaborators

  • The Hospital for Sick Children

    lead OTHER

Principal Investigators

  • Lisa Goos, PhD · Research Institute, Hospital for Sick Children

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Month
Max Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2023-10-31
Completion
2023-10-31

Countries

  • Canada

Study Locations

More Related Trials

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 NCT02364843 on ClinicalTrials.gov