Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
399 participants
INTERVENTIONAL
2008-08-31
2009-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
QUADRUPLE
Study Groups
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1
Marketed cow's milk-based formula
Infant formula
Marketed cow's milk base infant formula 20 kcal/oz
2
Cow's milk based formula with prebiotics, different level of fatty acids and fat and a different calcium source
Infant formula
cow's milk based infant formula with prebiotics, different level of fatty acids and fat and a different calcium source
3
Cow's milk based formula with prebiotic, different level of fatty acids and fat and a different calcium source
Cow's milk infant formula
Cow's milk based formula with prebiotics, different level of fatty acids and fat and a different calcium source
Interventions
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Infant formula
Marketed cow's milk base infant formula 20 kcal/oz
Infant formula
cow's milk based infant formula with prebiotics, different level of fatty acids and fat and a different calcium source
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 12-16 days of age
* 37-42 weeks GA
Exclusion Criteria
* Feeding difficulties or formula intolerance
* LGA
12 Days
16 Days
ALL
Yes
Sponsors
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Mead Johnson Nutrition
INDUSTRY
Responsible Party
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Mead Johnson & Company
Principal Investigators
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Carol L Berseth, MD
Role: STUDY_DIRECTOR
Mead Johnson & Company
Locations
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Birmingham Pediatric Group
Birmingham, Alabama, United States
Alabama Clinical Therapeutics
Dothan, Alabama, United States
Central Arkansas Pediatric Clinic
Benton, Arkansas, United States
Medical Associates
Fayetteville, Arkansas, United States
Arkansas Children's Hospital Research Institute
Little Rock, Arkansas, United States
Arkansas Pediatric Clinic
Little Rock, Arkansas, United States
Norwich Pediatric Group, PC
Norwich, Connecticut, United States
Palm Beach Clinical Investigation, LLC
West Palm Beach, Florida, United States
Welborn Clinic Research
Newburgh, Indiana, United States
Woburn Pediatric Associates Research Department
Woburn, Massachusetts, United States
Southwestern Medical Clinic, PC
Niles, Michigan, United States
Southwestern Medical Clinic, PC
Stevensville, Michigan, United States
Aspen Medical Group
Saint Paul, Minnesota, United States
The Center for Human Nutrition
Omaha, Nebraska, United States
Odyssey Research
Minot, North Dakota, United States
Red Lion Pediatrics
Philadelphia, Pennsylvania, United States
Primary Physicians Research, Inc
Pittsburgh, Pennsylvania, United States
Holston Medical Group, MeadowView Lane
Kingsport, Tennessee, United States
Holston Medical Group
Kingsport, Tennessee, United States
Retina Foundation of the Southwest
Dallas, Texas, United States
DCOL Center for Clinical Research
Longview, Texas, United States
Texas Tech University Health Sciences Center
Lubbock, Texas, United States
Countries
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References
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Ashley C, Johnston WH, Harris CL, Stolz SI, Wampler JL, Berseth CL. Growth and tolerance of infants fed formula supplemented with polydextrose (PDX) and/or galactooligosaccharides (GOS): double-blind, randomized, controlled trial. Nutr J. 2012 Jun 7;11:38. doi: 10.1186/1475-2891-11-38.
Other Identifiers
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3378-2
Identifier Type: -
Identifier Source: org_study_id