Tolerance and Efficacy of Wondersun Infant Formula in Formula-fed Chinese Term Infants
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
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Tolerance and Efficacy of Wondersun Infant Formula in Formula-fed Chinese Term Infants: an Open Label, Controlled Trial|
- Anthropometric parameters [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]body length, body weight, and head circumferences
- Efficacy and safety [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]Stool characteristics General health and wellbeing Behavior and habits Adverse events Concomitant medications Covariates or potential confounders
|Study Start Date:||February 2010|
|Study Completion Date:||June 2011|
|Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
Experimental: Infant formula
The infants will be fed with Wondersun infant formula with high proportion of palmitic acid at the sn-2 position
Other: Infant formula
Name: Infant formula with high proportion of palmitic acid in the sn-2 position Dosage & frequency: Fed as need Duration: at least 3 months
Other Name: Wondersun Brand An Li Cong Infant Formula
Active Comparator: Breast feeding
Complete breast feed within the first 3 month
Other: Breast feeding
Other Name: Not relevant
Please refer to this study by its ClinicalTrials.gov identifier: NCT01157390
|The Third Affiliated Hospital of Sun Yat-sen University|
|Guangzhou, Guangdong, China, 510630|
|Principal Investigator:||Yuming Chen, PhD||Sun Yat-sen University|