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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
History of Changes
  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:

Drug Information available for: Lutein
U.S. FDA Resources

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 May 19, 2013