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

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ClinicalTrials.gov Identifier: NCT00913406
Recruitment Status : Completed
First Posted : June 4, 2009
Last Update Posted : June 4, 2009
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

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

Condition or disease Intervention/treatment Phase
Healthy Other: Lutein fortification Other: Standard formula Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 232 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: Effect of Lutein in S-26 Gold on Growth and Safety
Study Start Date : November 2005
Actual Primary Completion Date : May 2006
Actual Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Experimental: 1
Experimental=Standard formula with lutein added to the formula
Other: Lutein fortification
Active Comparator: 2
Active Comparator=Standard formula
Other: Standard formula



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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 14 Days   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00913406     History of Changes
Other Study ID Numbers: 9041A1-902
First Posted: June 4, 2009    Key Record Dates
Last Update Posted: June 4, 2009
Last Verified: June 2009

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