NCT01157390

Tolerance and Efficacy of Wondersun Infant Formula in Formula-fed Chinese Term Infants

Tolerance and Efficacy of Wondersun Infant Formula in Formula-fed Chinese Term Infants: an Open Label, Controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 14 Days
• Healthy volunteers: Accepted

Summary

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

Conditions

• Infant Nutrition

Interventions

Type	Name	Description
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	Breast feeding	Breast feeding

Timeline

• Start date: 2010-02-01
• Primary completion: 2011-03-01
• Completion: 2011-06-01
• First posted: 2010-07-07
• Last updated: 2017-06-08

Locations

1 site across 1 country: China