The Evaluation of Cow's Milk Formula - Study B - Full Text View

Sponsored by:	Mead Johnson
Information provided by:	Mead Johnson
ClinicalTrials.gov Identifier:	NCT00712608

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

MedlinePlus related topics: Calcium Infant and Toddler Nutrition

U.S. FDA Resources

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

Further study details as provided by Mead Johnson:

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
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Marketed cow's milk-based formula	Other: Infant formula Marketed cow's milk base infant formula 20 kcal/oz
2: Experimental 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
3: Experimental 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

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
Alabama Clinical Therapeutics
Dothan, Alabama, United States, 36305
Birmingham Pediatric Group
Birmingham, Alabama, United States, 35205
United States, Arkansas
Arkansas Children's Hospital Research Institute
Little Rock, Arkansas, United States, 72202
Medical Associates
Fayetteville, Arkansas, United States, 72703
Arkansas Pediatric Clinic
Little Rock, Arkansas, United States, 72205
Central Arkansas Pediatric Clinic
Benton, Arkansas, United States, 72019
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
Stevensville, Michigan, United States, 49127
Southwestern Medical Clinic, PC
Niles, Michigan, United States, 49120
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
Primary Physicians Research, Inc
Pittsburgh, Pennsylvania, United States, 15241
Red Lion Pediatrics
Philadelphia, Pennsylvania, United States, 19114
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

Investigators

Study Director:

Carol L Berseth, MD

Mead Johnson & Company

More Information

No publications provided

Responsible Party:	Mead Johnson & Company ( Carol L. Berseth, MD, Director Medical Affairs North America )
Study ID Numbers:	3378-2
Study First Received:	July 8, 2008
Last Updated:	April 23, 2009
ClinicalTrials.gov Identifier:	NCT00712608 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Mead Johnson:

Term
Infant
Formula

Study placed in the following topic categories:

Calcium, Dietary
Healthy
Iron

ClinicalTrials.gov processed this record on May 07, 2009