Study Stopped
Study design changes were needed due to change of protocol to a multisite trial and updated set up
Effects of InFat™ Product on Stool Biochemistry and Stool Characteristics in Formula-fed Term Chinese Infants
Effects of InFat™ Product (High Sn-2 Palmitic Acid) on Stool Biochemistry and Stool Characteristics in Formula-fed Term Chinese Infants: a Triple-blind, Randomized, Placebo-controlled Trial
1 other identifier
interventional
80
1 country
1
Brief Summary
The purpose of this study is to demonstrate the efficacy of infant formula having proportion of palmitate in the sn-2 position comparable to human milk in Chinese term infants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 healthy
Started Sep 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 30, 2007
CompletedFirst Posted
Study publicly available on registry
May 31, 2007
CompletedStudy Start
First participant enrolled
September 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedJune 7, 2011
August 1, 2008
7 months
May 30, 2007
June 6, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Stool biochemistry - soaped fatty acids
6 weeks
Secondary Outcomes (4)
Stool biochemistry - total fatty acids and calcium content
6 weeks
Stool characteristics - 7days diaries
3 months
General health
3 months
Anthropometric parameters
3-6 months
Study Arms (2)
1
ACTIVE COMPARATORInfant formula with InFat™ oil(containing \~49% of C16:0 at sn-2 position).
2
PLACEBO COMPARATORStandard vegetable oil based infant formula
Interventions
Infant formula with InFat™ oil (containing \~49% of C16:0 at sn-2 position), 24 wk
Eligibility Criteria
You may qualify if:
- Term infants: gestation 37-40 weeks
- Birth weight 2500-4000 g
- Apparent good health
- The infant is a product of normal pregnancy and delivery.
You may not qualify if:
- Any maternal disease (psychological or disabled) or socioeconomic problems that may interfere with the mother's ability to take care of her infant
- Major congenital abnormality or chromosomal disorder with a clinical significance that can be detected at birth, clinically significant
- Disease requiring mechanical ventilation or medication treatment at the first week (not including photo treatment for infantile hepatitis)
- Born with a 5- or 10-minute Apgar score \<7
- Any suspected or known metabolic or physical limitations interfering with feeding or normal metabolism (require a special formula)
- Breast-feeding for a week or over.
- Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Enzymoteclead
Study Sites (1)
Sun Yat Sen University
Guangzhou, 510080, China
Study Officials
- PRINCIPAL INVESTIGATOR
Yi Xiang Su, MD Professor
Sun Yat-sen University
- PRINCIPAL INVESTIGATOR
Yuming Chen, PhD
Sun Yat-sen University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 30, 2007
First Posted
May 31, 2007
Study Start
September 1, 2008
Primary Completion
April 1, 2009
Study Completion
August 1, 2009
Last Updated
June 7, 2011
Record last verified: 2008-08