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CompletedNCT01157390Updated Jun 8, 2017

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

A Phase 4 interventional study of Infant formula and Breast feeding in Infant Nutrition, sponsored by Sun Yat-sen University. Completed at 1 site in China. Open to participants aged Up to 14 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-06-08.

Sponsored by Sun Yat-sen University · Phase 4, Interventional, and Supportive care

Phase
Phase 4
Study type
Interventional
Enrollment
75
Allocation
Non-randomized
Ages
Up to 14 Days
Sex
All
01

Study 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

02

Conditions studied

  • Infant Nutrition

Keywords

  • Term-infant
  • sn-2 palmitic acid
  • infant formula
03

In context

Lead sponsor

Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 14 Days
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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).
05

Study design

Phase
Phase 4
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
75 participants (actual)

Study arms

  • 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

  • Active comparator
    Breast feeding

    Complete breast feed within the first 3 month

    Other: Breast feeding

Interventions

  • OtherInfant 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

    Also known as: Wondersun Brand An Li Cong Infant Formula

  • OtherBreast feeding

    Breast feeding

    Also known as: Not relevant

06

What researchers measure

Primary outcomes

  1. Anthropometric parameters

    body length, body weight, and head circumferences

    Time frame: 12 weeks

Secondary outcomes

  1. Efficacy and safety

    Stool characteristics General health and wellbeing Behavior and habits Adverse events Concomitant medications Covariates or potential confounders

    Time frame: 6 weeks

07

Study locations

1 site
  • The Third Affiliated Hospital of Sun Yat-sen University
    Guangzhou, Guangdong 510630, China
08

References and documents

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
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 8, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01157390
Lead sponsor
Sun Yat-sen University
Collaborators
Enzymotec
Responsible party
Yu-ming Chen (Professor, Sun Yat-sen University) — Principal investigator
First posted
Jul 7, 2010
Start date
Feb 2010
Primary completion
Mar 2011
Completion
Jun 2011
Last update
Jun 8, 2017

Study contacts

Yuming Chen, PhD
principal investigator · Sun Yat-sen University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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