Effects on Growth of an Extensively Hydrolyzed Formula Fed to Term
NCT ID: NCT00936637
Last Updated: 2009-07-10
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
35 participants
INTERVENTIONAL
2007-07-31
2008-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
SINGLE
Study Groups
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Extensively hydrolyzed infant formula
Extensively hydrolyzed infant formula
Interventions
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Extensively hydrolyzed infant formula
Eligibility Criteria
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Inclusion Criteria
* Healthy, term (37-42 weeks) infant
* Weight for length between the 10th and 90th percentile according to the National Center for Health Statistics (NCHS) growth charts
* At time of enrollment:
* \< or = 21 days post-natal age
* Weight for length between the 10th and 90th percentile according to the National Center for Health Statistics (NCHS) growth charts
* Exclusively formula fed
* Written informed consent of parent/guardian
Exclusion Criteria
* Conditions requiring feedings other than those specified in the protocol
* Documented or suspected cow's milk allergy and/or soy protein allergies
* Major congenital deformities
* Suspected or documented systemic or congenital infections
* Evidence of cardiac, respiratory, hematological, gastrointestinal, or other systemic diseases
* Participation in any other clinical trial
1 Day
21 Days
ALL
Yes
Sponsors
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Perrigo Nutritionals
INDUSTRY
Responsible Party
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PBM Products
Principal Investigators
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Cynthia M Barber, PhD
Role: STUDY_DIRECTOR
Perrigo Nutritionals
Locations
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University of Virginia
Charlottesville, Virginia, United States
Countries
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Other Identifiers
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UVA Growth Study
Identifier Type: -
Identifier Source: org_study_id
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