Clinical trial NCT01157390: Tolerance and Efficacy of Wondersun Infant Formula in Formula-fed Chinese Term Infants
Official title: Tolerance and Efficacy of Wondersun Infant Formula in Formula-fed Chinese Term Infants: an Open Label, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infant Nutrition
Keywords: Term-infant
sn-2 palmitic acid
infant formula
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Enzymotec
First posted: 2010-07-07
Enrollment: 75
Sex: ALL
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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


Eligibility 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).

Primary outcomes:
measure: Anthropometric parameters
timeFrame: 12 weeks
Secondary outcomes:
measure: Efficacy and safety
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Third Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Yuming Chen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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