Infant Nutrition Clinical Trial
Official title:
Tolerance and Efficacy of Wondersun Infant Formula in Formula-fed Chinese Term Infants: an Open Label, Controlled Trial
Objective: To demonstrate the well-being of Chinese term infants fed with Wondersun formula
with high proportion of palmitic acid in the sn-2 position.
Design & setting: A single-center, open label study. A breast fed group will serve as
reference. The study will be conducted in Guangzhou from 2010.1~2010.12.
Participants: 0-14 d whole formula-fed infants and whole breast-fed infants, 30 infants in
each group. They are required to be healthy, term-infant, and with normal birth weight, and
have no medications known to affect their growth and development.
Intervention: The formula-fed infants will be fed Wondersun formula with high proportion of
palmitic acid in the sn-2 position; and breast-fed groups will be fed using breast milk for
at least 3 month.
Outcome measures: Tolerance and efficacy will be assessed by body measurement, stool
characteristics questionnaire, general health examination, and behavior and habit
questionnaire at baseline (0-14d), 6 weeks and 12 weeks. Safety will also be evaluated.
Statistical analysis: t-test, rank test and chi-square test will be used to examine the
significance of change from baseline to follow-up visit between the formula-fed and
breast-fed groups for effectiveness measures
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