Original articleHypoallergenicity and Effects on Growth and Tolerance of a New Amino Acid-Based Formula with Docosahexaenoic Acid and Arachidonic Acid
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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Cited by (0)
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]