Background/Objectives: Breast milk contains lutein derived from the mother's diet. This carotenoid is currently notadded to infant formula, which has a small and variable lutein content from innate ingredients. This study wasconducted to compare the growth of infants fed lutein-fortified infant formula with that of infants fed infant formulawithout lutein fortification.

Subjects/Methods: This 16-week study was prospective, randomized, controlled, and double-blind with parallelgroups of healthy term infants fed either control formula (Wyeth S-26 Gold, designated as Gold) or experimentalformula (Wyeth S-26 Gold fortified with lutein at 200 mcg/l, designated as Gold + Lutein). Two hundred thirty-two(232) infants ≤ 14 days postnatal age were randomized and 220 (94.8%) completed the study. Weight (g), headcircumference (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 studyand evaluation of selected blood chemistry tests performed at Week 16.

Results: Infants in both treatment groups demonstrated appropriate growth. No differences between treatmentgroups were found in any of the measures of growth at any of the measurement time points. Both study formulas werewell tolerated. The mean values of all measured blood chemistry parameters fell within the modified normal ranges forinfants, 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 unfortifiedlutein formula.

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