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

This study has been completed.
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer Identifier:
First received: May 28, 2009
Last updated: June 3, 2009
Last verified: June 2009
Study to determine if the addition of lutein to infant formula supports healthy growth and development in healthy full term infants.

Condition Intervention
Other: Lutein fortification
Other: Standard formula

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: Effect of Lutein in S-26 Gold on Growth and Safety

Resource links provided by NLM:

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • Weight gain/day in grams/day [ Time Frame: 4 months ]

Secondary Outcome Measures:
  • Collection of adverse experiences [ Time Frame: 4 months ]

Enrollment: 232
Study Start Date: November 2005
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Experimental=Standard formula with lutein added to the formula
Other: Lutein fortification
Active Comparator: 2
Active Comparator=Standard formula
Other: Standard formula


Ages Eligible for Study:   up to 14 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00913406

Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth Identifier: NCT00913406     History of Changes
Other Study ID Numbers: 9041A1-902
Study First Received: May 28, 2009
Last Updated: June 3, 2009

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Effect of lutein fortification growth healthy term infants processed this record on May 25, 2017