Randomized Multicenter Trial Documenting the Efficacy and Safety of a Lactose-Free and a Lactose-Containing Formula for Term Infants

Objective To evaluate the efficacy and safety of a new lactose-free infant formula. Design Randomized, prospective, double-blind, controlled, outpatient, multicenter, parallel 12-week trial. Setting Ambulatory-care facilities of the participating centers. Subjects 137 healthy term infants (approximately 7 days old at the time of study enrollment). Intervention Healthy term infants, whose mothers had decided not to breast-feed, were randomly assigned 1 of the 2 study formulas. Main outcome measures Weight, length, and occipitofrontal circumference measurements were obtained at baseline and when the infant was 2, 4, 8, and 12 weeks old. Formula acceptance and tolerance were also assessed at weeks 2, 4, 8, and 12. Serum albumin concentration, creatinine level, and blood urea nitrogen were determined at baseline and week 12. Adverse events were assessed throughout the study. Statistical analyses performed Each baseline anthropometric and laboratory variable was analyzed for comparability between groups using the Student t test and was also analyzed using a repeated-measures analysis of variance method. Covariance analysis was applied to the final laboratory data using the respective baseline data as covariates. Decisions about equality of mean responses to formula effects were based on the .05 level of significance in all cases. Results One hundred four infants completed the study. No significant differences between the 2 formula groups were noted for any of the growth and blood parameters. Applications This new formula is an effective and safe lactose-free nutrition alternative for infants who require such a diet. J Am Diet Assoc. 2000;100:212–217.