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

Wyeth is now a wholly owned subsidiary of Pfizer232 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

QUADRUPLE

Enrollment

232

Conditions

Healthy

Interventions

Lutein fortificationOTHER

Standard formulaOTHER

Eligibility

Sex: ALLMax age: 14 DaysHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Weight gain/day in grams/day

Time frame: 4 months

Secondary Outcomes

Collection of adverse experiences

Time frame: 4 months

Data from ClinicalTrials.gov

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