The Evaluation of Cow's Milk Formula - Study B
1 other identifier
interventional
399
1 country
22
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2008
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 8, 2008
CompletedFirst Posted
Study publicly available on registry
July 10, 2008
CompletedStudy Start
First participant enrolled
August 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedJanuary 28, 2010
April 1, 2009
1.2 years
July 8, 2008
January 26, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of weight gain
106 days
Secondary Outcomes (1)
length and head circumference
106 days
Study Arms (3)
1
ACTIVE COMPARATORMarketed cow's milk-based formula
2
EXPERIMENTALCow's milk based formula with prebiotics, different level of fatty acids and fat and a different calcium source
3
EXPERIMENTALCow's milk based formula with prebiotic, different level of fatty acids and fat and a different calcium source
Interventions
Marketed cow's milk base infant formula 20 kcal/oz
Cow's milk based formula with prebiotics, different level of fatty acids and fat and a different calcium source
Eligibility Criteria
You may qualify if:
- Term infant
- days of age
- weeks GA
You may not qualify if:
- History of chronic disease, congenital malformation
- Feeding difficulties or formula intolerance
- LGA
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Birmingham Pediatric Group
Birmingham, Alabama, 35205, United States
Alabama Clinical Therapeutics
Dothan, Alabama, 36305, United States
Central Arkansas Pediatric Clinic
Benton, Arkansas, 72019, United States
Medical Associates
Fayetteville, Arkansas, 72703, United States
Arkansas Children's Hospital Research Institute
Little Rock, Arkansas, 72202, United States
Arkansas Pediatric Clinic
Little Rock, Arkansas, 72205, United States
Norwich Pediatric Group, PC
Norwich, Connecticut, 06360, United States
Palm Beach Clinical Investigation, LLC
West Palm Beach, Florida, 33407, United States
Welborn Clinic Research
Newburgh, Indiana, 47630, United States
Woburn Pediatric Associates Research Department
Woburn, Massachusetts, 01801, United States
Southwestern Medical Clinic, PC
Niles, Michigan, 49120, United States
Southwestern Medical Clinic, PC
Stevensville, Michigan, 49127, United States
Aspen Medical Group
Saint Paul, Minnesota, 55108, United States
The Center for Human Nutrition
Omaha, Nebraska, 68105, United States
Odyssey Research
Minot, North Dakota, 58701, United States
Red Lion Pediatrics
Philadelphia, Pennsylvania, 19114, United States
Primary Physicians Research, Inc
Pittsburgh, Pennsylvania, 15241, United States
Holston Medical Group, MeadowView Lane
Kingsport, Tennessee, 37660, United States
Holston Medical Group
Kingsport, Tennessee, 37660, United States
Retina Foundation of the Southwest
Dallas, Texas, 75231, United States
DCOL Center for Clinical Research
Longview, Texas, 75605, United States
Texas Tech University Health Sciences Center
Lubbock, Texas, 79430, United States
Related Publications (1)
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.
PMID: 22676715DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Carol L Berseth, MD
Mead Johnson & Company
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 8, 2008
First Posted
July 10, 2008
Study Start
August 1, 2008
Primary Completion
October 1, 2009
Study Completion
October 1, 2009
Last Updated
January 28, 2010
Record last verified: 2009-04