Document Detail

Hypoallergenicity and effects on growth and tolerance of a new amino acid-based formula with docosahexaenoic acid and arachidonic acid.
MedLine Citation:
PMID:  18534230     Owner:  NLM     Status:  MEDLINE    
OBJECTIVE: In study 1, to compare the effect on growth in healthy infants of a new amino acid-based formula (AAF) and a control extensively hydrolyzed formula (EHF), with both docosahexaenoic acid (DHA) and arachidonic acid (ARA) at levels similar to those in human milk worldwide. In study 2, to evaluate the hypoallergenicity of this new AAF in infants and children with confirmed cow's milk allergy (CMA). STUDY DESIGN: In study 1, a total of 165 healthy, full-term, formula-fed infants randomly received the new AAF or control formula. Anthropometric measurements, tolerance, and adverse events were recorded throughout the study. Plasma amino acid profiles were evaluated in a subset of the infants. In study 2, the hypoallergenicity of the new AAF was evaluated in 32 infants and children using a double-blind, placebo-controlled food challenge; an open challenge; and a 7-day feeding. RESULTS: In study 1, overall growth, tolerance, and safety outcomes were similar in both groups. In study 2, 29 of the 32 subjects completed both challenges; no allergic reaction was seen in any of the 32 subjects. CONCLUSIONS: The new AAF with DHA and ARA at levels similar to those in human milk worldwide is hypoallergenic. It also is safe and supports growth in healthy, term infants.
Wesley Burks; Stacie M Jones; Carol Lynn Berseth; Cheryl Harris; Hugh A Sampson; Deolinda M F Scalabrin
Publication Detail:
Type:  Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2008-04-09
Journal Detail:
Title:  The Journal of pediatrics     Volume:  153     ISSN:  1097-6833     ISO Abbreviation:  J. Pediatr.     Publication Date:  2008 Aug 
Date Detail:
Created Date:  2008-07-21     Completed Date:  2008-08-13     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0375410     Medline TA:  J Pediatr     Country:  United States    
Other Details:
Languages:  eng     Pagination:  266-71     Citation Subset:  AIM; IM    
Department of Pediatrics, Duke University Medical Center, Durham, NC, USA.
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MeSH Terms
Amino Acids / administration & dosage*
Arachidonic Acid / administration & dosage*
Child, Preschool
Dietary Supplements
Docosahexaenoic Acids / administration & dosage*
Double-Blind Method
Growth / drug effects
Infant Food / adverse effects
Infant Formula / administration & dosage*
Infant, Newborn
Milk / adverse effects
Milk Hypersensitivity / diet therapy*,  etiology
Prospective Studies
Treatment Outcome
Reg. No./Substance:
0/Amino Acids; 25167-62-8/Docosahexaenoic Acids; 506-32-1/Arachidonic Acid
Comment In:
J Pediatr. 2008 Aug;153(2):A2   [PMID:  18639715 ]

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