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

Infant Nutrition Clinical Trial

Official title:

Tolerance and Efficacy of Wondersun Infant Formula in Formula-fed Chinese Term Infants: an Open Label, Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01157390
• Other study ID #: INF-004
• Status: Completed
• Phase: Phase 4
• First received: June 24, 2010
• Last updated: June 7, 2017
• Start date: February 2010
• Est. completion date: June 2011

Study information

• Verified date: June 2017
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: June 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 14 Days

Eligibility

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).

Related Conditions & MeSH terms

• Infant Nutrition

Intervention

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
• Breast feeding
Breast feeding

Locations

Country	Name	City	State
China	The Third Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Sun Yat-sen University	Enzymotec

Country where clinical trial is conducted

China, 

References & Publications (1)

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 Ma

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anthropometric parameters	body length, body weight, and head circumferences	12 weeks
Secondary	Efficacy and safety	Stool characteristics General health and wellbeing Behavior and habits Adverse events Concomitant medications Covariates or potential confounders	6 weeks