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

NCT02364843 | Terminated

• 1 other identifier: 1000048977
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Threonine; enteral feedings; infants; amino acid; requirements

Outcome Measures

Primary Outcomes (1)

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

  12 months

Study Arms (1)

Dietary Threonine Intake

EXPERIMENTAL

Physiological establishment of enteral intake of amino acid threonine required by infants ages 1 - 6 mos

Dietary Supplement: Amino Acid: Threonine

Interventions

Amino Acid: Threonine DIETARY_SUPPLEMENT

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

Dietary Threonine Intake

Eligibility Criteria

• Age: 1 Month - 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, Canada

Location

Related Publications (14)

• Chapman KP, Courtney-Martin G, Moore AM, Ball RO, Pencharz PB. Threonine requirement of parenterally fed postsurgical human neonates. Am J Clin Nutr. 2009 Jan;89(1):134-41. doi: 10.3945/ajcn.2008.26654. Epub 2008 Dec 3.

  PMID: 19056607 BACKGROUND

• Chapman KP, Courtney-Martin G, Moore AM, Langer JC, Tomlinson C, Ball RO, Pencharz PB. Lysine requirement in parenterally fed postsurgical human neonates. Am J Clin Nutr. 2010 Apr;91(4):958-65. doi: 10.3945/ajcn.2009.28729. Epub 2010 Feb 17.

  PMID: 20164307 BACKGROUND

• Courtney-Martin G, Chapman KP, Moore AM, Kim JH, Ball RO, Pencharz PB. Total sulfur amino acid requirement and metabolism in parenterally fed postsurgical human neonates. Am J Clin Nutr. 2008 Jul;88(1):115-24. doi: 10.1093/ajcn/88.1.115.

  PMID: 18614731 BACKGROUND

• Bertolo RF, Chen CZ, Law G, Pencharz PB, Ball RO. Threonine requirement of neonatal piglets receiving total parenteral nutrition is considerably lower than that of piglets receiving an identical diet intragastrically. J Nutr. 1998 Oct;128(10):1752-9. doi: 10.1093/jn/128.10.1752.

  PMID: 9772146 BACKGROUND

• Hogewind-Schoonenboom JE, Huang L, de Groof F, Zhu L, Voortman GJ, Schierbeek H, Vermes A, Chen C, Huang Y, van Goudoever JB. Threonine Requirement of the Enterally Fed Term Infant in the First Month of Life. J Pediatr Gastroenterol Nutr. 2015 Sep;61(3):373-9. doi: 10.1097/MPG.0000000000000807.

  PMID: 25844708 BACKGROUND

• Huang L, Hogewind-Schoonenboom JE, de Groof F, Twisk JW, Voortman GJ, Dorst K, Schierbeek H, Boehm G, Huang Y, Chen C, van Goudoever JB. Lysine requirement of the enterally fed term infant in the first month of life. Am J Clin Nutr. 2011 Dec;94(6):1496-503. doi: 10.3945/ajcn.111.024166. Epub 2011 Nov 2.

  PMID: 22049162 BACKGROUND

• Kramsch DM, Franzblau C, Hollander W. The protein and lipid composition of arterial elastin and its relationship to lipid accumulation in the atherosclerotic plaque. J Clin Invest. 1971 Aug;50(8):1666-77. doi: 10.1172/JCI106656.

  PMID: 5097573 BACKGROUND

• Law GK, Bertolo RF, Adjiri-Awere A, Pencharz PB, Ball RO. Adequate oral threonine is critical for mucin production and gut function in neonatal piglets. Am J Physiol Gastrointest Liver Physiol. 2007 May;292(5):G1293-301. doi: 10.1152/ajpgi.00221.2006. Epub 2007 Jan 18.

  PMID: 17234895 BACKGROUND

• Roberts SA, Ball RO, Moore AM, Filler RM, Pencharz PB. The effect of graded intake of glycyl-L-tyrosine on phenylalanine and tyrosine metabolism in parenterally fed neonates with an estimation of tyrosine requirement. Pediatr Res. 2001 Jan;49(1):111-9. doi: 10.1203/00006450-200101000-00022.

  PMID: 11134500 BACKGROUND

• Robinson C, Lowe NR, Weatherell JA. Amino acid composition, distribution and origin of "tuft" protein in human and bovine dental enamel. Arch Oral Biol. 1975 Jan;20(1):29-42. doi: 10.1016/0003-9969(75)90149-1. No abstract available.

  PMID: 1054568 BACKGROUND

• SNYDERMAN SE, NORTON PM, FOWLER DI, HOLT LE Jr. The essential amino acid requirements of infants: lysine. AMA J Dis Child. 1959 Feb;97(2):175-85. doi: 10.1001/archpedi.1959.02070010177004. No abstract available.

  PMID: 13616864 BACKGROUND

• Joint WHO/FAO/UNU Expert Consultation. Protein and amino acid requirements in human nutrition. World Health Organ Tech Rep Ser. 2007;(935):1-265, back cover.

  PMID: 18330140 BACKGROUND

• Zello GA, Pencharz PB, Ball RO. Dietary lysine requirement of young adult males determined by oxidation of L-[1-13C]phenylalanine. Am J Physiol. 1993 Apr;264(4 Pt 1):E677-85. doi: 10.1152/ajpendo.1993.264.4.E677.

  PMID: 8476044 BACKGROUND

• Zello GA, Wykes LJ, Ball RO, Pencharz PB. Recent advances in methods of assessing dietary amino acid requirements for adult humans. J Nutr. 1995 Dec;125(12):2907-15. doi: 10.1093/jn/125.12.2907.

  PMID: 7500168 BACKGROUND

MeSH Terms

Conditions

Tracheoesophageal Fistula; Pierre Robin Syndrome; Hernia, Diaphragmatic

Condition Hierarchy (Ancestors)

Esophageal Fistula; Digestive System Fistula; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Respiratory Tract Fistula; Respiratory Tract Diseases; Tracheal Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Internal Hernia; Hernia

Study Officials

• Lisa Goos, PhD

  Research Institute, Hospital for Sick Children

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: January 29, 2015
• First Posted: February 18, 2015
• Study Start: February 1, 2016
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: April 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)