NCT00913406

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
232

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Nov 2005

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

May 28, 2009

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 4, 2009

Completed
Last Updated

June 4, 2009

Status Verified

June 1, 2009

Enrollment Period

6 months

First QC Date

May 28, 2009

Last Update Submit

June 3, 2009

Conditions

Healthy

Keywords

Effect of lutein fortification growth healthy term infants

Outcome Measures

Primary Outcomes (1)

  • Weight gain/day in grams/day

    4 months

Secondary Outcomes (1)

  • Collection of adverse experiences

    4 months

Study Arms (2)

1

EXPERIMENTAL

Experimental=Standard formula with lutein added to the formula

Other: Lutein fortification

2

ACTIVE COMPARATOR

Active Comparator=Standard formula

Other: Standard formula

Interventions

Lutein fortificationOTHER
1
Standard formulaOTHER
2

Eligibility Criteria

AgeUp to 14 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy infants aged 0-14 days
  • Full Term birth and AGA Parent(s) signed informed consent

You may not qualify if:

  • Unhealthy infant
  • Participation in other clinical trial
  • Use of prohibited medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 28, 2009

First Posted

June 4, 2009

Study Start

November 1, 2005

Primary Completion

May 1, 2006

Study Completion

May 1, 2006

Last Updated

June 4, 2009

Record last verified: 2009-06