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

December 5, 2012 updated by: Mead Johnson Nutrition
The purpose is to determine if the consumption of study product has an effect on acute respiratory infections and/or diarrheal disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

310

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

  • China
    • Zhejiang
      • Jinhua, Zhejiang, China, 321000
        • Shi-ji-xing Child Care Center, Jin Dong District

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

3 years to 4 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Follow-On Formula
Powdered Follow-On Formula with added long-chain Polyunsaturated fatty acid, prebiotics, and polysaccharide
Dietary supplement: Follow-On Formula
Powdered Follow-On Formula with added long-chain Polyunsaturated fatty acid, prebiotics, and polysaccharide
Placebo Comparator: Cow's Milk
Powdered whole cow's milk
Dietary supplement: Cow's milk
Powdered whole cow's milk

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Acute respiratory infections and diarrheal disease
Time Frame: 28 weeks
28 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systemic antibiotic use
Time Frame: 28 weeks
28 weeks
Duration of acute respiratory infection and diarrheal disease
Time Frame: 28 weeks
28 weeks
Growth
Time Frame: 28 weeks
28 weeks
Allergic manifestations
Time Frame: 28 weeks
28 weeks
Changes in stool patterns
Time Frame: Baseline and 28 weeks
Baseline and 28 weeks
Fecal immune markers
Time Frame: Baseline and 28 weeks
Baseline and 28 weeks
Serum Ferritin status
Time Frame: Baseline and 28 weeks
Baseline and 28 weeks
Incidence of stool parasites
Time Frame: Baseline and 28 weeks
Baseline and 28 weeks
Adverse events
Time Frame: 28 weeks
The incidence of any adverse event for each participant
28 weeks
Acceptance of study product
Time Frame: 28 weeks
Acceptance of study product based on quantity consumed.
28 weeks
Serum immune markers
Time Frame: Baseline and 28 weeks
Baseline and 28 weeks
Serum zinc status
Time Frame: Baseline and 28 weeks
Baseline and 28 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mead Johnson Nutrition

Collaborators

Shanghai Children's Medical Center
Shanghai, China

Investigators

  • Principal Investigator: Xingming Jin, M.D., Professor of Development and Behavioral Pediatrics, Shanghai Children Medical Center

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.

General Publications

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

November 1, 2011

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

December 5, 2011

First Submitted That Met QC Criteria

December 6, 2011

First Posted (Estimate)

December 8, 2011

Study Record Updates

Last Update Posted (Estimate)

December 6, 2012

Last Update Submitted That Met QC Criteria

December 5, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6012 (Other)

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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