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

June 3, 2009 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

Effect of Lutein in S-26 Gold on Growth and Safety

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

232

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 2 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weight gain/day in grams/day
Time Frame: 4 months
4 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Collection of adverse experiences
Time Frame: 4 months
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (Actual)

May 1, 2006

Study Completion (Actual)

May 1, 2006

Study Registration Dates

First Submitted

May 28, 2009

First Submitted That Met QC Criteria

June 3, 2009

First Posted (Estimate)

June 4, 2009

Study Record Updates

Last Update Posted (Estimate)

June 4, 2009

Last Update Submitted That Met QC Criteria

June 3, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 9041A1-902

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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