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OpenTrials
Completed

NCT Number: NCT00913406

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.

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Key information

Conditions

Age range

Up to 14 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lutein fortification

Other

Standard formula

Other

Primary outcomes

  1. Weight gain/day in grams/day

    Time frame: 4 months

Secondary outcomes

  1. Collection of adverse experiences

    Time frame: 4 months

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Acronym: S-26 Gold L

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Jun 4, 2009
Registry last updated
Jun 4, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.