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Efficacy and Tolerance of a Follow-On Formula Fed to Children From 36-48 Months of Age

Primary Purpose

Acute Respiratory Infection, Diarrheal Disease

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Cow's milk
Follow-On Formula
Sponsored by
Mead Johnson Nutrition
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Respiratory Infection

Eligibility Criteria

36 Months - 48 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Child 36-48 months of age
  • 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 who received any food product or supplement containing probiotics or prebiotics in the 15 days prior to randomization
  • 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

Sites / Locations

  • Shi-ji-xing Child Care Center, Jin Dong District

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Cow's Milk

Follow-On Formula

Arm Description

Powdered whole cow's milk

Powdered Follow-On Formula with added long-chain Polyunsaturated fatty acid, prebiotics, and polysaccharide

Outcomes

Primary Outcome Measures

Acute respiratory infections and diarrheal disease

Secondary Outcome Measures

Allergic manifestations
Systemic antibiotic use
Duration of acute respiratory infection and diarrheal disease
Changes in stool patterns
Fecal immune markers
Serum Ferritin status
Incidence of stool parasites
Growth
Adverse events
The incidence of any adverse event for each participant
Acceptance of study product
Acceptance of study product based on quantity consumed.
Serum immune markers
Serum zinc status

Full Information

First Posted
December 5, 2011
Last Updated
December 5, 2012
Sponsor
Mead Johnson Nutrition
Collaborators
Shanghai Children's Medical Center, Shanghai, China
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1. Study Identification

Unique Protocol Identification Number
NCT01488435
Brief Title
Efficacy and Tolerance of a Follow-On Formula Fed to Children From 36-48 Months of Age
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mead Johnson Nutrition
Collaborators
Shanghai Children's Medical Center, Shanghai, China

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose is to determine if the consumption of study product has an effect on acute respiratory infections and/or diarrheal disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Infection, Diarrheal Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
310 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cow's Milk
Arm Type
Placebo Comparator
Arm Description
Powdered whole cow's milk
Arm Title
Follow-On Formula
Arm Type
Experimental
Arm Description
Powdered Follow-On Formula with added long-chain Polyunsaturated fatty acid, prebiotics, and polysaccharide
Intervention Type
Dietary Supplement
Intervention Name(s)
Cow's milk
Intervention Description
Powdered whole cow's milk
Intervention Type
Dietary Supplement
Intervention Name(s)
Follow-On Formula
Intervention Description
Powdered Follow-On Formula with added long-chain Polyunsaturated fatty acid, prebiotics, and polysaccharide
Primary Outcome Measure Information:
Title
Acute respiratory infections and diarrheal disease
Time Frame
28 weeks
Secondary Outcome Measure Information:
Title
Allergic manifestations
Time Frame
28 weeks
Title
Systemic antibiotic use
Time Frame
28 weeks
Title
Duration of acute respiratory infection and diarrheal disease
Time Frame
28 weeks
Title
Changes in stool patterns
Time Frame
Baseline and 28 weeks
Title
Fecal immune markers
Time Frame
Baseline and 28 weeks
Title
Serum Ferritin status
Time Frame
Baseline and 28 weeks
Title
Incidence of stool parasites
Time Frame
Baseline and 28 weeks
Title
Growth
Time Frame
28 weeks
Title
Adverse events
Description
The incidence of any adverse event for each participant
Time Frame
28 weeks
Title
Acceptance of study product
Description
Acceptance of study product based on quantity consumed.
Time Frame
28 weeks
Title
Serum immune markers
Time Frame
Baseline and 28 weeks
Title
Serum zinc status
Time Frame
Baseline and 28 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
36 Months
Maximum Age & Unit of Time
48 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Child 36-48 months of age 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 who received any food product or supplement containing probiotics or prebiotics in the 15 days prior to randomization 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xingming Jin, M.D.
Organizational Affiliation
Professor of Development and Behavioral Pediatrics, Shanghai Children Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shi-ji-xing Child Care Center, Jin Dong District
City
Jinhua
State/Province
Zhejiang
ZIP/Postal Code
321000
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
24843061
Citation
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.
Results Reference
derived

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Efficacy and Tolerance of a Follow-On Formula Fed to Children From 36-48 Months of Age

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