Lutein-fortified infant formula fed to healthy term infants: evaluation of growth effects and safety

Nutrition Journal

Table 1 Summary of Infant Demography, Baseline Characteristics, and Disposition

		Gold	Gold + Lutein	Total
		(n = 115)	(n = 115)	(n = 230)
Age (days)
	n	115	115	230
	mean ± SD	9.5 ± 3.42	10.0 ± 3.49	9.8 ± 3.46
	min - max	1 - 14	2 - 14	1 - 14
Gender
	Female (%)/Male (%)	60(52)/55(48)	58(50)/57(50)	118(51)/112(49)
Weight	Mean ± SD	3169.1 ± 306	3216.6 ± 355	3193 ± 331
Study Disposition (%) ¹
Infants Screened				240
Infants randomized²		116	116	232
Completed the Study		110 (95)	110 (95)	220 (95)
Discontinued the Study		6 (5)	6 (5)	12 (5)
Reason for study discontinuation (%)
Adverse Event		4 (3)	3 (3)	7 (3)
Parent/Legal Guardian Request		2 (2)	3 (3)	5 (2)

Population: Intention to Treat
n = Number of randomized subjects who received study formula.
¹ The denominator used to calculate percent for study demographics is the number of subjects who received study formula.
¹ The denominator used to calculate percent for study disposition entries is the number of subjects randomized.
² Two subjects were randomized (one in each formula group) but did not receive study formula.

ISSN: 1475-2891