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The Evaluation of Cow's Milk Formula - Study B

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ClinicalTrials.gov Identifier: NCT00712608
Recruitment Status : Completed
First Posted : July 10, 2008
Last Update Posted : January 28, 2010
Sponsor:
Information provided by:
Mead Johnson Nutrition

Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Term Infants Other: Infant formula Other: Cow's milk infant formula Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 399 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: The Evaluation of Cow's Milk Formula - Study B
Study Start Date : August 2008
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

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 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




Primary Outcome Measures :
  1. Rate of weight gain [ Time Frame: 106 days ]

Secondary Outcome Measures :
  1. length and head circumference [ Time Frame: 106 days ]


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Ages Eligible for Study:   up to 16 Days   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Children's Hospital Research Institute
Little Rock, Arkansas, United States, 72202
Arkansas Pediatric Clinic
Little Rock, Arkansas, United States, 72205
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, MeadowView Lane
Kingsport, Tennessee, United States, 37660
Holston Medical Group
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

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
First Posted: July 10, 2008    Key Record Dates
Last Update Posted: January 28, 2010
Last Verified: April 2009

Keywords provided by Mead Johnson Nutrition:
Term
Infant
Formula

Additional relevant MeSH terms:
Calcium, Dietary
Bone Density Conservation Agents
Physiological Effects of Drugs