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

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00913406
First received: May 28, 2009
Last updated: June 3, 2009
Last verified: June 2009
  Purpose

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


Condition Intervention
Healthy
Other: Lutein fortification
Other: Standard formula

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Collection of adverse experiences [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   up to 14 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00913406

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

No publications provided

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00913406     History of Changes
Other Study ID Numbers: 9041A1-902
Study First Received: May 28, 2009
Last Updated: June 3, 2009
Health Authority: Philippines: Bureau of Food and Drugs

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Effect of lutein fortification growth healthy term infants

ClinicalTrials.gov processed this record on April 16, 2014