The Evaluation of Cow's Milk Formula - Study B

January 26, 2010 updated by: Mead Johnson Nutrition
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

399

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Birmingham Pediatric Group
      • Dothan, Alabama, United States, 36305
        • Alabama Clinical Therapeutics
    • Arkansas
      • Benton, Arkansas, United States, 72019
        • Central Arkansas Pediatric Clinic
      • Fayetteville, Arkansas, United States, 72703
        • Medical Associates
      • Little Rock, Arkansas, United States, 72202
        • Arkansas Children's Hospital Research Institute
      • Little Rock, Arkansas, United States, 72205
        • Arkansas Pediatric Clinic
    • Connecticut
      • Norwich, Connecticut, United States, 06360
        • Norwich Pediatric Group, PC
    • Florida
      • West Palm Beach, Florida, United States, 33407
        • Palm Beach Clinical Investigation, LLC
    • Indiana
      • Newburgh, Indiana, United States, 47630
        • Welborn Clinic Research
    • Massachusetts
      • Woburn, Massachusetts, United States, 01801
        • Woburn Pediatric Associates Research Department
    • Michigan
      • Niles, Michigan, United States, 49120
        • Southwestern Medical Clinic, PC
      • Stevensville, Michigan, United States, 49127
        • Southwestern Medical Clinic, PC
    • Minnesota
      • St. Paul, Minnesota, United States, 55108
        • Aspen Medical Group
    • Nebraska
      • Omaha, Nebraska, United States, 68105
        • The Center for Human Nutrition
    • North Dakota
      • Minot, North Dakota, United States, 58701
        • Odyssey Research
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19114
        • Red Lion Pediatrics
      • Pittsburgh, Pennsylvania, United States, 15241
        • Primary Physicians Research, Inc
    • Tennessee
      • Kingsport, Tennessee, United States, 37660
        • Holston Medical Group
      • Kingsport, Tennessee, United States, 37660
        • Holston Medical Group, MeadowView Lane
    • Texas
      • Dallas, Texas, United States, 75231
        • Retina Foundation of the Southwest
      • Longview, Texas, United States, 75605
        • DCOL Center for Clinical Research
      • Lubbock, Texas, United States, 79430
        • Texas Tech University Health Sciences Center

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

1 week to 2 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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
Active Comparator: 1
Marketed cow's milk-based formula
Other: Infant formula
Marketed cow's milk base infant formula 20 kcal/oz
Other Names:
  • Similar to Enfamil LIPIL with iron
Other: Infant formula
cow's milk based infant formula with prebiotics, different level of fatty acids and fat and a different calcium source
Other Names:
  • No other similar brand names; experimental formula
Experimental: 2
Cow's milk based formula with prebiotics, different level of fatty acids and fat and a different calcium source
Other: Infant formula
Marketed cow's milk base infant formula 20 kcal/oz
Other Names:
  • Similar to Enfamil LIPIL with iron
Other: Infant formula
cow's milk based infant formula with prebiotics, different level of fatty acids and fat and a different calcium source
Other Names:
  • No other similar brand names; experimental formula
Experimental: 3
Cow's milk based formula with prebiotic, different level of fatty acids and fat and a different calcium source
Other: Cow's milk infant formula
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of weight gain
Time Frame: 106 days
106 days

Secondary Outcome Measures

Outcome Measure
Time Frame
length and head circumference
Time Frame: 106 days
106 days

Collaborators and Investigators

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

Sponsor

Mead Johnson Nutrition

Investigators

  • Study Director: Carol L Berseth, MD, Mead Johnson & Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

August 1, 2008

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

July 8, 2008

First Submitted That Met QC Criteria

July 9, 2008

First Posted (Estimate)

July 10, 2008

Study Record Updates

Last Update Posted (Estimate)

January 28, 2010

Last Update Submitted That Met QC Criteria

January 26, 2010

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 3378-2

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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