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OpenTrials
Completed

NCT Number: NCT00712608

The Evaluation of Cow's Milk Formula - Study B

A study to evaluate the growth and development of term infants fed either a marketed cow's milk formula, or an experimental cow's milk formula with prebiotics + a different calcium source + a different level of fatty acids and fat, or an experimental cow's milk formula with prebiotic + a different calcium source + a different level of fatty acids and fat

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Key information

Age range

12 day–16 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Birmingham Pediatric Group, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Term infant
  • 12-16 days of age
  • 37-42 weeks GA

Exclusion criteria

  • History of chronic disease, congenital malformation
  • Feeding difficulties or formula intolerance
  • LGA

Treatment and study plan

Infant Formula

Other

Marketed cow's milk base infant formula 20 kcal/oz

Other names: Similar to Enfamil LIPIL with iron

Cow's milk infant formula

Other

Cow's milk based formula with prebiotics, different level of fatty acids and fat and a different calcium source

Other names: No other similar brand names; experimental product

Primary outcomes

  1. Rate of weight gain

    Time frame: 106 days

Secondary outcomes

  1. length and head circumference

    Time frame: 106 days

Sponsors and collaborators

Lead sponsor

Mead Johnson Nutrition

Industry

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jul 10, 2008
Registry last updated
Jan 28, 2010

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.

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