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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Mead Johnson Nutrition

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 July 22, 2014