Clinical trial NCT00712608: The Evaluation of Cow's Milk Formula - Study B
Official title: The Evaluation of Cow's Milk Formula - Study B
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Term Infants
Keywords: Term
Infant
Formula
Lead sponsor: Mead Johnson Nutrition
Sponsor class: INDUSTRY
First posted: 2008-07-10
Enrollment: 399
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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


Eligibility 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

Primary outcomes:
measure: Rate of weight gain
timeFrame: 106 days
Secondary outcomes:
measure: length and head circumference
timeFrame: 106 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Pediatric Group
state: Alabama
city: Dothan
country: United States
facility: Alabama Clinical Therapeutics
state: Alabama
city: Benton
country: United States
facility: Central Arkansas Pediatric Clinic
state: Arkansas
city: Fayetteville
country: United States
facility: Medical Associates
state: Arkansas
city: Little Rock
country: United States
facility: Arkansas Children's Hospital Research Institute
state: Arkansas
city: Little Rock
country: United States
facility: Arkansas Pediatric Clinic
state: Arkansas
city: Norwich
country: United States
facility: Norwich Pediatric Group, PC
state: Connecticut
city: West Palm Beach
country: United States
facility: Palm Beach Clinical Investigation, LLC
state: Florida
city: Newburgh
country: United States
facility: Welborn Clinic Research
state: Indiana
city: Woburn
country: United States
facility: Woburn Pediatric Associates Research Department
state: Massachusetts
city: Niles
country: United States
facility: Southwestern Medical Clinic, PC
state: Michigan
city: Stevensville
country: United States
facility: Southwestern Medical Clinic, PC
state: Michigan
city: St. Paul
country: United States
facility: Aspen Medical Group
state: Minnesota
city: Omaha
country: United States
facility: The Center for Human Nutrition
state: Nebraska
city: Minot
country: United States
facility: Odyssey Research
state: North Dakota
city: Philadelphia
country: United States
facility: Red Lion Pediatrics
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Primary Physicians Research, Inc
state: Pennsylvania
city: Kingsport
country: United States
facility: Holston Medical Group, MeadowView Lane
state: Tennessee
city: Kingsport
country: United States
facility: Holston Medical Group
state: Tennessee
city: Dallas
country: United States
facility: Retina Foundation of the Southwest
state: Texas
city: Longview
country: United States
facility: DCOL Center for Clinical Research
state: Texas
city: Lubbock
country: United States
facility: Texas Tech University Health Sciences Center
state: Texas
Study officials:
affiliation: Mead Johnson & Company
name: Carol L Berseth, MD
role: STUDY_DIRECTOR
References:
citation: 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.