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

This study has been completed.
Sponsor:
Collaborators:
Shanghai Children Medical Center
Shanghai, China
Information provided by (Responsible Party):
Mead Johnson Nutrition
ClinicalTrials.gov Identifier:
NCT01488435
First received: December 5, 2011
Last updated: December 5, 2012
Last verified: December 2012
  Purpose

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


Condition Intervention
Acute Respiratory Infection
Diarrheal Disease
Dietary Supplement: Cow's milk
Dietary Supplement: Follow-On Formula

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Further study details as provided by Mead Johnson Nutrition:

Primary Outcome Measures:
  • Acute respiratory infections and diarrheal disease [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Allergic manifestations [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
  • Systemic antibiotic use [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
  • Duration of acute respiratory infection and diarrheal disease [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
  • Changes in stool patterns [ Time Frame: Baseline and 28 weeks ] [ Designated as safety issue: No ]
  • Fecal immune markers [ Time Frame: Baseline and 28 weeks ] [ Designated as safety issue: No ]
  • Serum Ferritin status [ Time Frame: Baseline and 28 weeks ] [ Designated as safety issue: No ]
  • Incidence of stool parasites [ Time Frame: Baseline and 28 weeks ] [ Designated as safety issue: No ]
  • Growth [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
    The incidence of any adverse event for each participant

  • Acceptance of study product [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
    Acceptance of study product based on quantity consumed.

  • Serum immune markers [ Time Frame: Baseline and 28 weeks ] [ Designated as safety issue: No ]
  • Serum zinc status [ Time Frame: Baseline and 28 weeks ] [ Designated as safety issue: No ]

Enrollment: 310
Study Start Date: November 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Cow's Milk
Powdered whole cow's milk
Dietary Supplement: Cow's milk
Powdered whole cow's milk
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

  Eligibility

Ages Eligible for Study:   36 Months to 48 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01488435

Locations
China, Zhejiang
Shi-ji-xing Child Care Center, Jin Dong District
Jinhua, Zhejiang, China, 321000
Sponsors and Collaborators
Mead Johnson Nutrition
Shanghai Children Medical Center
Shanghai, China
Investigators
Principal Investigator: Xingming Jin, M.D. Professor of Development and Behavioral Pediatrics, Shanghai Children Medical Center
  More Information

No publications provided

Responsible Party: Mead Johnson Nutrition
ClinicalTrials.gov Identifier: NCT01488435     History of Changes
Other Study ID Numbers: 6012
Study First Received: December 5, 2011
Last Updated: December 5, 2012
Health Authority: China: Shanghai Nutrition Society IRB

Additional relevant MeSH terms:
Respiratory Tract Infections
Diarrhea
Infection
Respiratory Tract Diseases
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on April 22, 2014