The aim of the study is to assess age-appropriate growth of healthy infants fed a new organic milk-based infant formula.
A 16-weeks length, randomized, controlled, double-blind, parallel study designed to evaluate growth and tolerance of healthy infants fed milk-based infant formula. The study has been designed in accordance with Good Clinical Practice guidelines and the requirements of the Code of Federal Regulations 21 CFR 106.96
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
176
Powder, standard commercial infant formula.
Powder, organic milk-based infant formula.
TeleResearch Hub
Cary, North Carolina, United States
Formula intake.
Volume of formula consumed. ml/day
Time frame: Study Day 1 to Study Day 112
Weight.
Weight. Weight gain velocity. g and g/day
Time frame: Study Day 1 to Study Day 112
Length.
Length. Length gain velocity. cm and cm/day.
Time frame: Study Day 1 to Study Day 112
Head circumference.
Head circumference. Head circumference gain velocity. cm and cm/day
Time frame: Study Day 1 to Study Day 112
Anthropometry Z-scores.
Weight for age Z-score. Length for age Z-score. Weight for length Z-score. Head circumference for age Z-score.
Time frame: Study Day 1 to Study Day 112
Formula tolerance.
Frequency of adverse events. Fussiness. Inconsolable crying.
Time frame: Study Day 1 to Study Day 112
Gastrointestinal characteristic.
Stool consistency. Stools/day. Regurgitation. Gas.
Time frame: Study Day 1 to Study Day 112
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