The primary objective is to determine if the weight gain of healthy term infants fed a commercially available term infant formula supplemented with DHASCO® is similar to that of infants fed the same formula supplemented with a new product, DHASCO®-B.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
159
Claude Ashley, MD
Dothan, Alabama, United States
JBRKIDS
Jonesboro, Arkansas, United States
Norwich Pediatric
Norwich, Connecticut, United States
Score Physician Alliance
weight gain (gm/day)
gm/day -calculated from the weight measured at enrollment subtracted from the weight measured at DOL 120 visit, divided by the number of days between the actual visits.
Time frame: through day of life 120
length (cm)
Length in cm
Time frame: through day of life 120
head circumference (cm)
head circumference (cm)
Time frame: through day of life 120
fatty acid levels (wgt %)
red blood cell (RBC) levels of omega-3 and omega-6 fatty acids (wgt %) in a sample subset
Time frame: at day of life 120
Formula intake and tolerance
assessed by analyzing three-day dietary intake and tolerance forms
Time frame: Day of life 30 and 120
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