Effect of Lutein in S-26 Gold On Growth And Safety (S-26 Gold L)

Wyeth

Status: Completed

Conditions: Healthy

Treatments: Other: Standard formula; Other: Lutein fortification

Study type: Interventional

Funder types: Industry

Identifiers

NCT00913406

9041A1-902

Details and patient eligibility

About

Study to determine if the addition of lutein to infant formula supports healthy growth and development in healthy full term infants.

Enrollment: 232 patients

Sex: All

Ages: Under 14 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy infants aged 0-14 days
• Full Term birth and AGA Parent(s) signed informed consent

Exclusion criteria

• Unhealthy infant
• Participation in other clinical trial
• Use of prohibited medications

Trial design

232 participants in 2 patient groups

1

Experimental group

Description:

Experimental=Standard formula with lutein added to the formula

Treatment:

Other: Lutein fortification

2

Active Comparator group

Description:

Active Comparator=Standard formula

Treatment:

Other: Standard formula