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

NCT01157390 | Completed Phase 4

• 1 other identifier: INF-004
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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

Keywords

Term-infant; sn-2 palmitic acid; infant formula

Outcome Measures

Primary Outcomes (1)

• Anthropometric parameters

  body length, body weight, and head circumferences

  12 weeks

Secondary Outcomes (1)

• Efficacy and safety

  6 weeks

Study Arms (2)

Infant formula

EXPERIMENTAL

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

Other: Infant formula

Breast feeding

ACTIVE COMPARATOR

Complete breast feed within the first 3 month

Other: Breast feeding

Interventions

Infant formula 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

Also known as: Wondersun Brand An Li Cong Infant Formula

Infant formula

Breast feeding OTHER

Breast feeding

Also known as: Not relevant

Breast feeding

Eligibility Criteria

• Age: Up to 14 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Enzymotec: collaborator

Study Sites (1)

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510630, China

Location

Related 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 Mar 15; 4(2): 00122. DOI: 10.15406/jnhfe.2016.04.00122

  RESULT

MeSH Terms

Interventions

Infant Formula; Lactation

Intervention Hierarchy (Ancestors)

Milk Substitutes; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food, Formulated; Foods, Specialized; Food; Infant Food; Food and Beverages; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Postpartum Period

Study Officials

• Yuming Chen, PhD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 24, 2010
• First Posted: July 7, 2010
• Study Start: February 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: June 1, 2011
• Last Updated: June 8, 2017

Record last verified: 2017-06

Locations

CN (1)