Status:
COMPLETED
Effect of the Level of Dietary Protein on Infant Growth
Lead Sponsor:
Société des Produits Nestlé (SPN)
Conditions:
Infant Nutrition
Eligibility:
All Genders
3-12 years
Phase:
NA
Brief Summary
The purpose of this study is to determine whether infants fed a formula with protein levels different than a standard infant formula have similar growth and development.
Eligibility Criteria
Inclusion
- Gestational age at least 37 weeks
- Singleton birth
- Birth weight between 2500g and 4500g
- Weight at enrolment is at or above the 5th percentile (CDC)
- Infant has been exclusively formula fed for at least the last 14 days
- Having obtained informed consent of legal representative
Exclusion
- Congenital illness or malformation that affects infant feeding and/or growth
- Significant pre-natal and/or post-natal disease
- Suspected or confirmed allergy to cow milk protein
- In the investigators assessment, infant's family cannot be expected to comply with treatment (feeding regimen)
- Currently participating in another clinical trial
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
405 Patients enrolled
Trial Details
Trial ID
NCT00716105
Start Date
August 1 2008
End Date
February 1 2015
Last Update
May 19 2015
Active Locations (2)
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1
The Samuel J. Fomon Infant Nutrition Unit Dept of Pediatrics, University of Iowa
Iowa City, Iowa, United States, 52242
2
Department of Pediatrics University of Oklahoma Health Sciences
Oklahoma City, Oklahoma, United States, 73102