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Completed

NCT Number: NCT00779753

Determination of Lysine Requirement in the Parenterally Fed Neonate

The purpose of this study is to establish the parenteral lysine requirements for neonates.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hospital for Sick Children

Toronto, Ontario, Canada

About this study

It is important to identify the appropriate level of lysine requirements for parenterally fed neonates as this amino acid is the limiting amino acid in the diet of neonates. Feeding lysine at requirement improves the likelihood that other amino acids will be utilized appropriately for building proteins. In addition, lysine plays a major role in calcium absorption, development of muscle proteins and in the production of hormones, enzymes and antibodies. We believe that the lysine requirement will be 158 mg/kg/day which is significantly lower than the current 267 and 327 mg/kg/d that is found in the current Trophamine and Primene parenteral solutions.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinically stable neonates on TPN
  • minimum of 2.5 g/kg/d protein and 85 - 90 kcal/kg/d)
  • Post conception age of ≥ 34 weeks gestation and appropriate for gestational age
  • Weight of ≥ 1.5 kg
  • NPO or ≤10% of total protein requirement consumed enterally

Exclusion criteria

  • Infants on mechanical ventilators, supplemental oxygen or who are receiving medications that would alter protein or energy metabolism (ie. corticosteroid therapy, etc)

Treatment and study plan

Amino Acid Solution with different amount of Lysine

Dietary Supplement

The infants will be placed on a standard Primene solution for the first 24 hours of the study to obtain baseline values. During the second 24 hours they will receive an amino acid solution that has a different amount of lysine currently found in Primene, all lipid, CHO, minerals, vitamins and trace elements will remain unchanged. The Parenteral lysine will be studied at the following intake levels: 100, 110, 120, 130, 135, 140, 145, 150 , 155, 165, 170, 180, 200, 230, 245, 260mg/kg/d. The minimum energy intake will be 85-90 kcal/kg/day.

Other names: Trophamine, Primene

Primary outcomes

  1. Oxydation of the Indicator Amino Acid L-[1-13C] phenylalanine will be measured through urine samples to determine urinary phenylalanine enrichment

    Time frame: 2 days

Secondary outcomes

  1. Breath samples will be collected for the measurement of CO2 enrichment in expired air

    Time frame: 2 days

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Oct 24, 2008
Registry last updated
Aug 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.