Effect of the Level of Dietary Protein on Infant Growth
Not Applicable
Completed
- Conditions
- Infant Nutrition
- Registration Number
- NCT00716105
- Lead Sponsor
- Société des Produits Nestlé (SPN)
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 405
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Mean weight gain 6 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
The Samuel J. Fomon Infant Nutrition Unit Dept of Pediatrics, University of Iowa
🇺🇸Iowa City, Iowa, United States
Department of Pediatrics University of Oklahoma Health Sciences
🇺🇸Oklahoma City, Oklahoma, United States
The Samuel J. Fomon Infant Nutrition Unit Dept of Pediatrics, University of Iowa🇺🇸Iowa City, Iowa, United States