Assessment of Feeding Tolerance in Infants Fed Cow Milk Formula
NCT ID: NCT00666120
Last Updated: 2008-04-24
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
333 participants
INTERVENTIONAL
2005-06-30
2006-04-30
Brief Summary
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Hypothesize there will be no difference between formula groups.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
QUADRUPLE
Study Groups
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1
Cow's milk based infant formula
Enfamil LIPIL with iron
cow's milk based infant formula
2
Partially hydrolyzed cow's milk based infant formula
Good Start Supreme with DHA and ARA
partially hydrolzed cow's milk protein
Interventions
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Enfamil LIPIL with iron
cow's milk based infant formula
Good Start Supreme with DHA and ARA
partially hydrolzed cow's milk protein
Eligibility Criteria
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Inclusion Criteria
* Term infant at birth
* Birth weight of 2500 g (5 lbs 8 oz) or more
* 4 - 18 days of age at Study Visit 1
Exclusion Criteria
* Infant switched formulas more than one time between birth and Study Visit 1
* Known feeding problems at Study Visit 1
4 Days
18 Days
ALL
Yes
Sponsors
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Mead Johnson Nutrition
INDUSTRY
Responsible Party
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Mead Johnson
Principal Investigators
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Carol Berseth, MD
Role: STUDY_DIRECTOR
Mead Johnson Nutrition
Locations
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Harvey Pediatrics
Jonesboro, Arkansas, United States
Mercy Rogers Pediatric Clinic
Rogers, Arkansas, United States
Lovelace Scientific Resources
Santa Ana, California, United States
Tampa Bay Medical Research
Clearwater, Florida, United States
Children's Medical Association
Tamarac, Florida, United States
Children's Health Care
DeKalb, Illinois, United States
Welborn Clinic
Evansville, Indiana, United States
Fomon Infant Nutrition Unit
Iowa City, Iowa, United States
Heartland Research Associates
Wichita, Kansas, United States
Pediatrics Clinical Trials Unit
Louisville, Kentucky, United States
Pedia Research
Owensboro, Kentucky, United States
Arklatex Children's Center
Bossier City, Louisiana, United States
Craig Spiegel, MD
Bridgeton, Missouri, United States
The Center for Human Nutrition
Omaha, Nebraska, United States
Boystown
Omaha, Nebraska, United States
Winthrop Pediatric Associates
Mineola, New York, United States
Cary Pediatric Center
Cary, North Carolina, United States
Collom and Carney Clinic
Texarkana, Texas, United States
Countries
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References
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Berseth CL, Mitmesser SH, Ziegler EE, Marunycz JD, Vanderhoof J. Tolerance of a standard intact protein formula versus a partially hydrolyzed formula in healthy, term infants. Nutr J. 2009 Jun 19;8:27. doi: 10.1186/1475-2891-8-27.
Other Identifiers
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3370-6
Identifier Type: -
Identifier Source: org_study_id