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

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 Overview

• Status: Completed
• Conditions: Infant Nutrition
• Intervention / Treatment: Other: Infant formula; Other: Breast feeding

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510630
      • The Third Affiliated Hospital of Sun Yat-sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 weeks (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Parental/legal guardian written informed consent.
• The mother had unequivocally decided not to breast-feed (for formula fed infants) or to breastfeed (for human milk fed infants).
• Term infant of Chinese origin born at 37-42 gestation weeks as determined by menstrual history and corroborated by prenatal Unltra-Sound (US) and/or physical examination.
• Birth weight appropriate for gestational age (AGA), 2500-4000g (between 10th~ 90th percentile of body weight at same gestation age).
• The infant is apparent healthy at birth and entry to study.
• Apgar after 5 minutes >7.
• Enrolled within their first 14 days after birth.
• The infant is a product of normal pregnancy and delivery including C-section.
• Patental ability to attend visits, interviews and willing to fill questionnaires.

Exclusion Criteria:

• Mother health condition: (psychological of physical) or socioeconomic problems that may interfere with the mother's ability to take care of her infant.
• The infant suffers from a major congenital abnormality or chromosomal disorder with a clinical significance that can be detected at birth.
• The infant suffers/ed from a disease requiring mechanical ventilation or medication treatment at the first week after birth.
• The infant suffers from any suspected or known metabolic or physical limitations interfering with feeding or normal metabolism (require a special formula).
• The infant is a carry of HBV (HBsAb positive).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Wondersun Brand An Li Cong Infant Formula
Active Comparator: Breast feeding; Complete breast feed within the first 3 month	Other: Breast feeding; Breast feeding; Other Names: Not relevant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anthropometric parameters	body length, body weight, and head circumferences	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy and safety	Stool characteristics General health and wellbeing Behavior and habits Adverse events Concomitant medications Covariates or potential confounders	6 weeks

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Collaborators: Enzymotec
• Investigators: Principal Investigator: Yuming Chen, PhD, Sun Yat-sen University

Publications and helpful links

General Publications

• Zhong W, Tang XY, Hou HY, Liora L, Yael L, Yonatan M, Fabiana BY, Wei M, Su YX, Chen YM.Tolerance and Efficacy of Infant Formula with High Sn-2 Palmitate in Formula- Fed Chinese Term Infants: an Open Label, Controlled Trial. J Nutr Health Food Eng 2016 Mar 15; 4(2): 00122. DOI: 10.15406/jnhfe.2016.04.00122

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: June 24, 2010
• First Submitted That Met QC Criteria: July 6, 2010
• First Posted (Estimate): July 7, 2010

Study Record Updates

• Last Update Posted (Actual): June 8, 2017
• Last Update Submitted That Met QC Criteria: June 7, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: infant formula; Term-infant; sn-2 palmitic acid
• Other Study ID Numbers: INF-004