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

Sponsor
Sun Yat-sen University (Other)
Overall Status
Completed
CT.gov ID
NCT01157390
Collaborator
Enzymotec (Industry)
75
Enrollment
1
Location
2
Arms
15.9
Duration (Months)
4.7
Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
  • Other: Infant formula
  • Other: Breast feeding
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
75 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (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
Study Start Date :
Feb 1, 2010
Actual Primary Completion Date :
Mar 1, 2011
Actual Study Completion Date :
Jun 1, 2011

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Anthropometric parameters [12 weeks]

      body length, body weight, and head circumferences

    Secondary Outcome Measures

    1. Efficacy and safety [6 weeks]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 14 Days
    Sexes Eligible for Study:
    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:

    • 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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Third Affiliated Hospital of Sun Yat-sen University Guangzhou Guangdong China 510630

    Sponsors and Collaborators

    • Sun Yat-sen University
    • Enzymotec

    Investigators

    • Principal Investigator: Yuming Chen, PhD, Sun Yat-sen University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yu-ming Chen, Professor, Sun Yat-sen University
    ClinicalTrials.gov Identifier:
    NCT01157390
    Other Study ID Numbers:
    • INF-004
    First Posted:
    Jul 7, 2010
    Last Update Posted:
    Jun 8, 2017
    Last Verified:
    Jun 1, 2017
    Keywords provided by Yu-ming Chen, Professor, Sun Yat-sen University
    Term-infant
    sn-2 palmitic acid
    infant formula

    Study Results

    No Results Posted as of Jun 8, 2017