NCT00779753

Determination of Lysine Requirement in the Parenterally Fed Neonate

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: The Hospital for Sick Children · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Parenteral Lysine Requirements
• Parenteral Feedings

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Amino Acid Solution with different amount of Lysine	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.

Timeline

• Start date: 2008-07-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2008-10-24
• Last updated: 2013-08-05

Locations

1 site across 1 country: Canada