Infant NutritionPhase 4NCT01157390
Tolerance and Efficacy of Wondersun Infant Formula in Formula-fed Chinese Term Infants
A Phase 4 study testing Infant formula and Breast feeding in people with Infant Nutrition, run by Sun Yat-sen University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages Up to 14 daysHealthy volunteers can take part
- Conditions the study is for
- Infant Nutrition
- What is being tested?
- Infant formula and Breast feeding
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteChina
- Study dates
- Feb 2010to Jun 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 14 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
China1 site
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630
About this study
Official title: Tolerance and Efficacy of Wondersun Infant Formula in Formula-fed Chinese Term Infants: an Open Label, Controlled Trial
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.
Read more
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
- Being tested
- Infant formula, Breast feeding
- Keywords
- Term-infant, sn-2 palmitic acid, infant formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infant formulaOther
Also called Wondersun Brand An Li Cong 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 feedingOther
Also called Not relevant
Breast feeding
| Study group | Role | What they receive |
|---|---|---|
| Infant formula | Experimental | The infants will be fed with Wondersun infant formula with high proportion of palmitic acid at the sn-2 position Receives: Other: Infant formula |
| Breast feeding | Active comparator | Complete breast feed within the first 3 month Receives: Other: Breast feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anthropometric parameters
body length, body weight, and head circumferences
Measured: 12 weeks
Secondary outcomes (1)
Efficacy and safety
Stool characteristics General health and wellbeing Behavior and habits Adverse events Concomitant medications Covariates or potential confounders
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2010 (estimated)
- Study startFeb 2010
- Primary completionMar 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infant NutritionStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Enzymotec
- Responsible party
- Principal investigator, Yu-ming Chen, Sun Yat-sen University
- Investigators
- Yuming Chen, PhD, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01157390
- Sponsor's protocol ID
- INF-004
- Status last verified
- Jun 2017
- First submitted
- 24 Jun 2010
- Last updated
- 8 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerance and Efficacy of Wondersun Infant Formula in Formula-fed Chinese Term Infants: an Open Label, Controlled Trial
- ClinicalTrials.gov ID
- NCT01157390
- Acronym / sponsor ID
- INF-004
- Conditions
- Infant Nutrition
- Keywords
- Term-infant, sn-2 palmitic acid, infant formula
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Enzymotec
- Study start
- Feb 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 7 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infant formula | Experimental | Other: Infant formulaThe infants will be fed with Wondersun infant formula with high proportion of palmitic acid at the sn-2 position |
| Breast feeding | Active comparator | Other: Breast feedingComplete breast feed within the first 3 month |
Who may qualify
- Ages
- Up to 14 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infant formulaAlso: Wondersun Brand An Li Cong Infant FormulaName: Infant formula with high proportion of palmitic acid in the sn-2 position Dosage \& frequency: Fed as need Duration: at least 3 months | Other | Infant formula |
| Breast feedingAlso: Not relevantBreast feeding | Other | Breast feeding |
Primary outcome
Anthropometric parameters
Time frame: 12 weeks
body length, body weight, and head circumferences
1 secondary outcome
Efficacy and safety
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2017.
- Results publicationZhong 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuming Chen, PhD principal investigator
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Infant formula and Breast feeding in people with Infant Nutrition, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anthropometric parameters (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01157390, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2017.