TY - JOUR
T1 - Hypoallergenicity and Effects on Growth and Tolerance of a New Amino Acid-Based Formula with Docosahexaenoic Acid and Arachidonic Acid
AU - Burks, Wesley
AU - Jones, Stacie M.
AU - Berseth, Carol Lynn
AU - Harris, Cheryl
AU - Sampson, Hugh A.
AU - Scalabrin, Deolinda M.F.
N1 - Funding Information:
Supported by a grant from Mead Johnson Nutritionals. D. S. wrote the first draft of the manuscript as an employee of Mead Johnson Nutritionals.
PY - 2008/8
Y1 - 2008/8
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=47049090864&partnerID=8YFLogxK
U2 - 10.1016/j.jpeds.2008.02.043
DO - 10.1016/j.jpeds.2008.02.043
M3 - Article
C2 - 18534230
AN - SCOPUS:47049090864
SN - 0022-3476
VL - 153
SP - 266
EP - 271
JO - Journal of Pediatrics
JF - Journal of Pediatrics
IS - 2
ER -