Hypoallergenicity and effects on growth and tolerance of a new amino acid-based formula with docosahexaenoic acid and arachidonic acid

J Pediatr. 2008 Aug;153(2):266-71. doi: 10.1016/j.jpeds.2008.02.043. Epub 2008 Apr 9.


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.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Amino Acids / administration & dosage*
  • Animals
  • Arachidonic Acid / administration & dosage*
  • Child
  • Child, Preschool
  • Dietary Supplements
  • Docosahexaenoic Acids / administration & dosage*
  • Double-Blind Method
  • Female
  • Growth / drug effects
  • Humans
  • Infant
  • Infant Food / adverse effects
  • Infant Formula / administration & dosage*
  • Infant, Newborn
  • Male
  • Milk / adverse effects
  • Milk Hypersensitivity / diet therapy*
  • Milk Hypersensitivity / etiology
  • Prospective Studies
  • Treatment Outcome


  • Amino Acids
  • Docosahexaenoic Acids
  • Arachidonic Acid