- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01373541
Effect of InFat™ Product on Stool Biochemistry and Stool Characteristics in Formula-fed Term Infants in China
February 11, 2014 updated by: Enzymotec
Effect of InFat™ Product on Stool Biochemistry and Stool Characteristics in Formula-fed Term Infants in China: a Double Blind, Multi-center, Randomized, Controlled Trial
The purpose of this study is to determine the effect of infant formula with high percentage of palmitic acid at the sn-2 position (InFat™) on improving fat absorption and general gastrointestinal tolerance in Chinese formula-fed term infants.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The purpose of this study is to assess the efficacy of infant formula with high percentage of palmitic acid at the sn-2 position (InFat™) as compared to standard vegetable oil based infant formula on general gastrointestinal tolerance and fat absorption, reducing calcium soaps formation and stool hardness in Chinese formula-fed term infants.
Study Type
Interventional
Enrollment (Actual)
171
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Shanghai, China
- Rui Jin Hospital - Shanghai Jiao Tong University School of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 day to 2 weeks (CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
- Birth weight appropriate for gestational age (AGA), 2500-4000grams
- The infant is apparently healthy at birth and entry of study.
Exclusion Criteria:
- Adverse maternal, fetal or infant medical history that can potentially affect efficacy parameters, tolerance, growth and/or development
- The infant is not a singleton newborn
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: InFat group
Infant formula with structured triglycerides (high palmitic acid content at the sn-2 position)
|
high sn-2 palmitic acid oil based infant formula
Other Names:
|
ACTIVE_COMPARATOR: Control group
Infant formula with standard vegetable blend (low palmitic acid content at the sn-2 position)
|
standard vegetable oil based infant formula
Other Names:
|
NO_INTERVENTION: Referance group
Human milk breastfeeding
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Soaped and total fatty acids content in infant's stool samples collected at the age of 6 weeks and measured by stool biochemistry analysis
Time Frame: 6 postnatal weeks
|
6 postnatal weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Anthropometric parameters: body length, body weight, and head circumferences at each visit
Time Frame: Baseline, 6, 12 and 24 postnatal weeks
|
Baseline, 6, 12 and 24 postnatal weeks
|
Dietary, stool consistency and well being recorded by 3 day questionnaires
Time Frame: 6, 12 and 24 postnatal weeks
|
6, 12 and 24 postnatal weeks
|
Number of participants with adverse events and concomitant medications as a measure of safety and tolerability
Time Frame: Baseline, 6,12 and 24 postnatal weeks
|
Baseline, 6,12 and 24 postnatal weeks
|
Bone speed of sound measured by ultrasonic device at each visit
Time Frame: Baseline, 6,12 and 24 postnatal weeks
|
Baseline, 6,12 and 24 postnatal weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Xu Chundix, Prof., Ruijin Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2011
Primary Completion (ACTUAL)
December 1, 2012
Study Completion (ACTUAL)
May 1, 2013
Study Registration Dates
First Submitted
June 13, 2011
First Submitted That Met QC Criteria
June 14, 2011
First Posted (ESTIMATE)
June 15, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
February 13, 2014
Last Update Submitted That Met QC Criteria
February 11, 2014
Last Verified
January 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- InFat_003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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