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


METHODS
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.
Burks
Wesley
W
Department of Pediatrics, Duke University Medical Center, Durham, NC, USA.
Jones
Stacie M
SM
Berseth
Carol Lynn
CL
Harris
Cheryl
C
Sampson
Hugh A
HA
Scalabrin
Deolinda M F
DM
D000596:Amino Acids / Q000008:administration & dosage*; D000818:Animals; D016718:Arachidonic Acid / Q000008:administration & dosage*; D002648:Child; D002675:Child, Preschool; D019587:Dietary Supplements; D004281:Docosahexaenoic Acids / Q000008:administration & dosage*; D004311:Double-Blind Method; D005260:Female; D006128:Growth / Q000187:drug effects; D006801:Humans; D007223:Infant; D007225:Infant Food / Q000009:adverse effects; D041943:Infant Formula / Q000008:administration & dosage*; D007231:Infant, Newborn; D008297:Male; D008892:Milk / Q000009:adverse effects; D016269:Milk Hypersensitivity / Q000178:diet therapy* / Q000209:etiology; D011446:Prospective Studies; D016896:Treatment Outcome
D000596:Amino Acids; D004281:Docosahexaenoic Acids; D016718:Arachidonic Acid