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

NCT ID: NCT01157390

Last Updated: 2017-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2011-06-30

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

Conditions

Infant Nutrition

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Infant formula

The infants will be fed with Wondersun infant formula with high proportion of palmitic acid at the sn-2 position

Group Type: EXPERIMENTAL

Infant formula

Intervention Type: OTHER

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

Complete breast feed within the first 3 month

Group Type: ACTIVE_COMPARATOR

Breast feeding

Intervention Type: OTHER

Breast feeding

Interventions

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

Intervention Type: OTHER

Breast feeding

Breast feeding

Intervention Type: OTHER

Other Intervention Names

Wondersun Brand An Li Cong Infant Formula; Not relevant

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).

• Maximum Eligible Age: 14 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Enzymotec

INDUSTRY

Sponsor Role: collaborator

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Yu-ming Chen

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yuming Chen, PhD

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Countries

China

References

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

Reference Type: RESULT

Other Identifiers

INF-004

Identifier Type: -

Identifier Source: org_study_id