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

Last updated on November 14, 2019

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Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0-14
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy infants aged 0-14 days

- Full Term birth and AGA Parent(s) signed informed consent

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Unhealthy infant

- Participation in other clinical trial

- Use of prohibited medications

NCT00913406
Pfizer
Completed
Effect of Lutein in S-26 Gold On Growth And Safety

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Descriptive Information
Brief Title  ICMJE Effect of Lutein in S-26 Gold On Growth And Safety
Official Title  ICMJE Effect of Lutein in S-26 Gold on Growth and Safety
Brief SummaryStudy to determine if the addition of lutein to infant formula supports healthy growth and development in healthy full term infants.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Condition  ICMJE Healthy
Intervention  ICMJE
  • Other: Lutein fortification
  • Other: Standard formula
Study Arms  ICMJE
  • Experimental: 1
    Experimental=Standard formula with lutein added to the formula
    Intervention: Other: Lutein fortification
  • Active Comparator: 2
    Active Comparator=Standard formula
    Intervention: Other: Standard formula
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 3, 2009)
232
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2006
Actual Primary Completion DateMay 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE up to 14 Days   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00913406
Other Study ID Numbers  ICMJE 9041A1-902
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyWyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS AccountWyeth is now a wholly owned subsidiary of Pfizer
Verification DateJune 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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