Original article
Hypoallergenicity and Effects on Growth and Tolerance of a New Amino Acid-Based Formula with Docosahexaenoic Acid and Arachidonic Acid

https://doi.org/10.1016/j.jpeds.2008.02.043Get rights and content

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.

Section snippets

Study design and population

This double-blind, randomized, controlled, parallel-design, prospective trial was conducted at 14 clinical sites in the United States. Healthy, term infants 14 ± 2 days of age who were fed only formula for at least 24 hours before randomization were stratified by sex and randomly assigned to 1 of 2 study groups: the control group, who received a casein EHF (Nutramigen LIPIL; Mead Johnson Nutritionals, Evansville, Indiana), and the experimental group, who received the new AAF, which was of

Study 1

Of the 165 infants enrolled (1 infant who enrolled but dropped out before consuming any study formula was not included in any analyses) between October 2004 and June 2005, 110 (58 in the experimental group and 52 in the control group) completed the study. The infants in the 2 groups were similar in terms of mean (± standard error) weight, length, and head circumference at birth and at study entry (entry weight, 3742.4 ± 61.2 g in the control group, 3716.7 ± 61.1 g in the experimental group;

Discussion

The AAP states that infants who develop symptoms of food allergy may benefit from the use of an EHF or an AAF.8 Preclinical in vitro studies have demonstrated the absence of any detectable cow's milk protein in the experimental AAF tested in the current studies (data on file). Our 2 studies were designed to evaluate the safety and tolerability of the new AAF and to demonstrate its hypoallergenicity in vivo. The results of these studies demonstrate that the new AAF is hypoallergenic, safe, well

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Supported by a grant from Mead Johnson Nutritionals. D. S. wrote the first draft of the manuscript as an employee of Mead Johnson Nutritionals.

Reprint requests: Susan Hazels Mitmesser, PhD, Mead Johnson Nutritionals, 2400 W Lloyd Expressway, Evansville, IN 47721. E-mail: [email protected]

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