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The Evaluation of Cow's Milk Formula - Study B

This study has been completed.
Sponsor:
Information provided by:
Mead Johnson Nutrition
ClinicalTrials.gov Identifier:
NCT00712608
First received: July 8, 2008
Last updated: January 26, 2010
Last verified: April 2009
History of Changes
  Purpose

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


Condition Intervention
Healthy Term Infants
 Other: Infant formula
Other: Cow's milk infant formula

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: The Evaluation of Cow's Milk Formula - Study B

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mead Johnson Nutrition:

Primary Outcome Measures:
  • Rate of weight gain [ Time Frame: 106 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • length and head circumference [ Time Frame: 106 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 399
Study Start Date: August 2008
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Marketed cow's milk-based formula
 Other: Infant formula
Marketed cow's milk base infant formula 20 kcal/oz
Other Name: Similar to Enfamil LIPIL with iron
Experimental: 2
Cow's milk based formula with prebiotics, different level of fatty acids and fat and a different calcium source
 Other: Infant formula
cow's milk based infant formula with prebiotics, different level of fatty acids and fat and a different calcium source
Other Name: 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 Name: No other similar brand names; experimental product

  Eligibility

Ages Eligible for Study:   up to 16 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00712608

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

No publications provided by Mead Johnson Nutrition

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Carol L. Berseth, MD, Director Medical Affairs North America, Mead Johnson & Company
ClinicalTrials.gov Identifier: NCT00712608     History of Changes
Other Study ID Numbers: 3378-2
Study First Received: July 8, 2008
Last Updated: January 26, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Mead Johnson Nutrition:
Term
Infant
Formula

ClinicalTrials.gov processed this record on May 23, 2013