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临床试验/NCT02364843
NCT02364843终止不适用

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

The Hospital for Sick Children1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2016年2月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
2
试验地点
1
主要终点
Effect of increasing threonine intakes on breath F13CO2 in enterally fed infants ages 1 - 6 months

研究概览

简要总结

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.

详细描述

INTRODUCTION

Threonine is an indispensable AA that must come from dietary sources. It is critical in the production of mucins in the gut (Law, Bertolo et al. 2007) and contributes significantly to collagen, elastin and tooth enamel formation (Kramsch, Franzblau et al. 1971, Robinson, Lowe et al. 1975). The current adequate intake (AI) for threonine in infants proposed by the Institute of Medicine, Food and Nutrition Board, in the 2005 Dietary Reference Intakes (DRIs) for macronutrients is based on a factorial approach due to the lack of conclusive empirical data. Studies that lead to the determination of amino acid (AA) requirements for infants used the nitrogen analysis technique and were performed over 20 years ago (Snyderman, Norton et al. 1959). Methodological advances have made it possible to determine AA requirements in humans with a more precise technique (Zello, Wykes et al. 1995). However, no studies of threonine requirement in infants (1- 6mo of age) with the use of the newer stable-isotope methods have been reported.

To accurately determine amino acid requirements, it is necessary to provide a range of amino acid intakes. For ethical reasons, infants cannot be fed very low or high test amino acid diets for prolonged periods of time. The minimally invasive IAAO method, initially developed in adults in our laboratory (Zello, Pencharz et al. 1993) and now used internationally (Huang, Hogewind-Schoonenboom et al. 2011) to determine amino acid requirements, overcomes this problem. The IAAO method takes less than 24 hours to conduct and has been used safely in parenterally fed neonates, enterally fed neonates, children and adults.

Our laboratory determined the enteral requirement of threonine in piglets (Bertolo, Chen et al. 1998) which was 0.42g/kg/d. We are able to extrapolate from this data, and propose that the enteral requirement for neonates would be 84 mg/kg/d. In this study we will be determining the enteral requirement for the 1 - 6 months old infant and predict that since growth slows and protein requirement decreases after the first month of life, the enteral requirement of infants will be similar to the DRI's AI of 73 mg/kg/d. Thus, the objective of this study is to determine the enteral Threonine requirement in infants from 1 to 6 months of age with the IAAO method.

SUBJECTS AND METHODS

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
1 Month 至 6 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Between ages 1 - 6 months
  • Born between 32 and 43 weeks gestational age
  • Clinically stable (normal vital signs and blood values)
  • Fed by nasogastric (NG), jejunal (J or NJ), or gastric (G) tube

排除标准

  • Infants will be excluded if they are receiving supplemental oxygen
  • Mechanically ventilated
  • Have any endocrine or genetic anomalies that affect protein or AA metabolism
  • On medications that influence protein and AA metabolism (ex: corticosteroid therapy)

结局指标

主要结局

Effect of increasing threonine intakes on breath F13CO2 in enterally fed infants ages 1 - 6 months

时间窗: 12 months

We will be conducting 18 enteral feeding studies using 18 different intakes of threonine and measuring the effects on F13CO2 in breath samples and 13C-Phenylalanine in urine samples

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Paul Pencharz

MD PhD

The Hospital for Sick Children

研究点 (1)

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