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

This study has been completed.
Sponsor:
Collaborator:
Enzymotec
Information provided by (Responsible Party):
Yu-ming Chen, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01157390
First received: June 24, 2010
Last updated: February 7, 2012
Last verified: February 2012
  Purpose

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 Intervention Phase
Infant Nutrition
Other: Infant formula
Other: Breast feeding
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • Anthropometric parameters [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    body length, body weight, and head circumferences


Secondary Outcome Measures:
  • 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


Enrollment: 75
Study Start Date: February 2010
Study Completion Date: June 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Breast feeding
Other Name: Not relevant

  Eligibility

Ages Eligible for Study:   up to 14 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01157390

Locations
China, Guangdong
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
  More Information

No publications provided

Responsible Party: Yu-ming Chen, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01157390     History of Changes
Other Study ID Numbers: INF-004
Study First Received: June 24, 2010
Last Updated: February 7, 2012
Health Authority: China: Ministry of Health

Keywords provided by Sun Yat-sen University:
Term-infant
sn-2 palmitic acid
infant formula

Additional relevant MeSH terms:
Palmitic Acid
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014