Growth and Tolerance of Young Infants Fed Infant Formulas
NCT ID: NCT01380886
Last Updated: 2013-02-15
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
PHASE3
209 participants
INTERVENTIONAL
2011-06-30
2011-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Infant formula, alternate protein source
Experimental infant formula with alternate protein source
experimental infant formula with alternate protein source
experimental infant formula to be fed ad libitum
Infant formula powder
Infant formula powder
Infant formula powder
powdered infant formula to be fed ad libitum
Interventions
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experimental infant formula with alternate protein source
experimental infant formula to be fed ad libitum
Infant formula powder
powdered infant formula to be fed ad libitum
Eligibility Criteria
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Inclusion Criteria
* full term
* birth weight \> 2490 g
* 0 to 8 days of age
* parent/physician agree to not use medications affecting tolerance/growth
* parent agrees to sole source feeding of study formula
* parent agrees to not use vitamin/mineral supplements
* parent has signed consent/HIPAA authorization
Exclusion Criteria
* participation in any other study not preapproved by Abbott
8 Days
ALL
Yes
Sponsors
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Abbott Nutrition
INDUSTRY
Responsible Party
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Principal Investigators
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Marlene Borschel, PhD
Role: STUDY_CHAIR
Abbott Nutrition
Locations
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Norwich Pediatric Group, PC
Norwich, Connecticut, United States
SCORE Physician Alliance, LLC
St. Petersburg, Florida, United States
Northpoint Pedicatrics, LLC
Indianapolis, Indiana, United States
Springs Medical Research, LLC
Owensboro, Kentucky, United States
Clinical Research Center of Nevada
Las Vegas, Nevada, United States
Cary Pediatric Center
Cary, North Carolina, United States
MetroHealth Medical Center
Cleveland, Ohio, United States
Ohio Pediatric Research Association, INC.
Huber Heights, Ohio, United States
Institute of Clinical Research
Mayfield Heights, Ohio, United States
The Cleveland Pediatric Research Center
Parma, Ohio, United States
Sanford Clinic Family Medicine
Sioux Falls, South Dakota, United States
DCOL Center for Clinical Research
Longview, Texas, United States
Countries
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Other Identifiers
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AK92
Identifier Type: -
Identifier Source: org_study_id
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