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.


METHODS
Randomized, prospective, double-blind, controlled, outpatient, multicenter, parallel 12-week trial.


METHODS
Ambulatory-care facilities of the participating centers.


METHODS
137 healthy term infants (approximately 7 days old at the time of study enrollment).


METHODS
Healthy term infants, whose mothers had decided not to breast-feed, were randomly assigned 1 of the 2 study formulas.


METHODS
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, creatirune level, and blood urea nitrogen were determined at baseline and week 12. Adverse events were assessed throughout the study.


METHODS
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.


CONCLUSIONS
This new formula is an effective and safe lactose-free nutrition alternative for infants who require such a diet.
Heubi
J
J
Division of Pediatric Gastroenterology and Nutrition, Children's Hospital Medical Center, Cincinnati, Ohio, USA.
Karasov
R
R
Reisinger
K
K
Blatter
M
M
Rosenberg
L
L
Vanderhoof
J
J
Darden
P M
PM
Safier
J
J
Martin
T
T
Euler
A R
AR
D000886:Anthropometry; D001806:Blood Urea Nitrogen; D003404:Creatinine / Q000097:blood; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007225:Infant Food / Q000009:adverse effects / Q000592:standards*; D007231:Infant, Newborn / Q000097:blood / Q000254:growth & development*; D007785:Lactose / Q000008:administration & dosage*; D008297:Male; D012709:Serum Albumin / Q000032:analysis
D012709:Serum Albumin; D003404:Creatinine; D007785:Lactose