Effects of Early Nutrition on Growth
This trial is active, not recruiting.
|Treatments||human milk, investigational infant formula, milk based standard infant formula|
|Collaborator||Institute of Child Health|
|Start date||March 2010|
|End date||September 2013|
|Trial size||649 participants|
|Trial identifier||NCT01300000, AK65|
The primary objective of the study is to compare the growth of infants fed standard infant formula with infants fed a reduced calorie and protein formula.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
time frame: 1- 365 days
time frame: 1-365 days
time frame: 1 - 365 days; 24 months
Male or female participants up to 24 hours old.
Inclusion Criteria: - good health - singleton birth with gestational age 37-42 weeks - infant's birth weight >or = to 2500 grams - exclusive breastfeeding or exclusively formula feeding - within a defined geographical boundary - mother has no problems communicating in English Exclusion Criteria: - adverse maternal, fetal or infant medical history - congenital disease or malformation affecting growth or development - illness or social problems in mother or infant - temporary residents
|Official title||Effects of Early Nutrient Intake on Growth and Body Composition|
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