Tolerance and Efficacy of Wondersun Infant Formula in Formula-fed Chinese Term Infants
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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 |
- Anthropometric parameters [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]body length, body weight, and head circumferences
- 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 |
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| China, Guangdong | |
| The Third Affiliated Hospital of Sun Yat-sen University | |
| Guangzhou, Guangdong, China, 510630 | |
| Principal Investigator: | Yuming Chen, PhD | Sun Yat-sen University |
More Information
Additional 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 May 16, 2013