Lutein-fortified infant formula fed to healthy term infants: evaluation of growth effects and safety.
OBJECTIVE
Breast milk contains lutein derived from the mother's diet. This carotenoid is currently not added to infant formula, which has a small and variable lutein content from innate ingredients. This study was conducted to compare the growth of infants fed lutein-fortified infant formula with that of infants fed infant formula without lutein fortification.


METHODS
This 16-week study was prospective, randomized, controlled, and double-blind with parallel groups of healthy term infants fed either control formula (Wyeth S-26 Gold, designated as Gold) or experimental formula (Wyeth S-26 Gold fortified with lutein at 200 mcg/l, designated as Gold+Lutein). Two hundred thirty-two (232) infants<or=14 days postnatal age were randomized and 220 (94.8%) completed the study. Weight (g), head circumference (cm), and length (cm) were measured at Weeks 4, 8, 12, and 16. The primary endpoint was weight gain (g/day) from baseline to Week 16. Safety was assessed through monitoring of study events (SEs) throughout the study and evaluation of selected blood chemistry tests performed at Week 16.


RESULTS
Infants in both treatment groups demonstrated appropriate growth. No differences between treatment groups were found in any of the measures of growth at any of the measurement time points. Both study formulas were well tolerated. The mean values of all measured blood chemistry parameters fell within the modified normal ranges for infants, and the values for both groups for any measured parameter were similar.


CONCLUSIONS
Infants fed lutein-fortified S-26 Gold demonstrated growth equivalent to that of infants fed unfortified lutein formula.
Capeding
Rosario
R
Asian Hospital and Medical Center, Medical Office Building, Civic Drive, Filinvest, Alabang, Muntinlupa City, Philippines.
Gepanayao
Connie P
CP
Calimon
Nerrisa
N
Lebumfacil
Jowena
J
Davis
Anne M
AM
Stouffer
Nicole
N
Harris
Bruce J
BJ
D001827:Body Height; D002508:Cephalometry; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D041943:Infant Formula / Q000008:administration & dosage / Q000737:chemistry*; D007231:Infant, Newborn / Q000254:growth & development*; D014975:Lutein / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008423:Maternal Age; D010679:Philippines; D011446:Prospective Studies; D015430:Weight Gain / Q000187:drug effects*
D014975:Lutein