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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01488435
First Posted: December 8, 2011
Last Update Posted: December 6, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Shanghai Children's Medical Center
Shanghai, China
Information provided by (Responsible Party):
Mead Johnson Nutrition
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]

Secondary Outcome Measures:
  • Allergic manifestations [ Time Frame: 28 weeks ]
  • Systemic antibiotic use [ Time Frame: 28 weeks ]
  • Duration of acute respiratory infection and diarrheal disease [ Time Frame: 28 weeks ]
  • Changes in stool patterns [ Time Frame: Baseline and 28 weeks ]
  • Fecal immune markers [ Time Frame: Baseline and 28 weeks ]
  • Serum Ferritin status [ Time Frame: Baseline and 28 weeks ]
  • Incidence of stool parasites [ Time Frame: Baseline and 28 weeks ]
  • Growth [ Time Frame: 28 weeks ]
  • Adverse events [ Time Frame: 28 weeks ]
    The incidence of any adverse event for each participant

  • Acceptance of study product [ Time Frame: 28 weeks ]
    Acceptance of study product based on quantity consumed.

  • Serum immune markers [ Time Frame: Baseline and 28 weeks ]
  • Serum zinc status [ Time Frame: Baseline and 28 weeks ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   36 Months to 48 Months   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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's Medical Center
Shanghai, China
Investigators
Principal Investigator: Xingming Jin, M.D. Professor of Development and Behavioral Pediatrics, Shanghai Children Medical Center
  More Information

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
First Submitted: December 5, 2011
First Posted: December 8, 2011
Last Update Posted: December 6, 2012
Last Verified: December 2012

Additional relevant MeSH terms:
Respiratory Tract Infections
Infection
Respiratory Tract Diseases