Efficacy and Tolerance of a Follow-On Formula Fed to Children From 36-48 Months of Age
NCT ID: NCT01488435
Last Updated: 2012-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
310 participants
INTERVENTIONAL
2011-11-30
2012-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Cow's Milk
Powdered whole cow's milk
Cow's milk
Powdered whole cow's milk
Follow-On Formula
Powdered Follow-On Formula with added long-chain Polyunsaturated fatty acid, prebiotics, and polysaccharide
Follow-On Formula
Powdered Follow-On Formula with added long-chain Polyunsaturated fatty acid, prebiotics, and polysaccharide
Interventions
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Cow's milk
Powdered whole cow's milk
Follow-On Formula
Powdered Follow-On Formula with added long-chain Polyunsaturated fatty acid, prebiotics, and polysaccharide
Eligibility Criteria
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Inclusion Criteria
* Child is currently attending a daycare and has attended for 6 months or less
* Has consumed cow's milk or a cow's milk-based beverage during the 48 hours prior to randomization
* Signed informed consent
Exclusion Criteria
* Child with allergy to gluten or serious concurrent illness that will interfere in the general management of the child
* Child with diarrhea or acute respiratory infection during the 48 hours prior to randomization
* Child's z-score of weight for height \< -3 according to World Health Organization criteria
36 Months
48 Months
ALL
Yes
Sponsors
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Shanghai Children's Medical Center
OTHER
Shanghai, China
UNKNOWN
Mead Johnson Nutrition
INDUSTRY
Responsible Party
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Principal Investigators
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Xingming Jin, M.D.
Role: PRINCIPAL_INVESTIGATOR
Professor of Development and Behavioral Pediatrics, Shanghai Children Medical Center
Locations
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Shi-ji-xing Child Care Center, Jin Dong District
Jinhua, Zhejiang, China
Countries
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References
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Li F, Jin X, Liu B, Zhuang W, Scalabrin D. Follow-up formula consumption in 3- to 4-year-olds and respiratory infections: an RCT. Pediatrics. 2014 Jun;133(6):e1533-40. doi: 10.1542/peds.2013-3598. Epub 2014 May 19.
Other Identifiers
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6012
Identifier Type: -
Identifier Source: org_study_id