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Efficacy and Tolerance of a Follow-On Formula Fed to Children From 12-48 Months of Age in Salvador, Bahia, Brazil

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ClinicalTrials.gov Identifier: NCT01431469
Recruitment Status : Completed
First Posted : September 9, 2011
Last Update Posted : December 6, 2012
Sponsor:
Collaborator:
Federal University of Bahia
Information provided by (Responsible Party):
Mead Johnson Nutrition

Tracking Information
First Submitted Date  ICMJE August 31, 2011
First Posted Date  ICMJE September 9, 2011
Last Update Posted Date December 6, 2012
Study Start Date  ICMJE September 2011
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 8, 2011)
Episodes of acute respiratory infections and diarrheal disease [ Time Frame: 28 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 8, 2011)
  • Occurrence of 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: 28 weeks ]
  • Fecal and serum immune markers [ Time Frame: 28 weeks ]
  • Serum Ferritin and Zinc status [ Time Frame: 28 weeks ]
  • Incidence of stool parasites [ Time Frame: 28 weeks ]
  • Growth [ Time Frame: 28 weeks ]
  • Incidence of 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Tolerance of a Follow-On Formula Fed to Children From 12-48 Months of Age in Salvador, Bahia, Brazil
Official Title  ICMJE Not Provided
Brief Summary The purpose is to determine if the consumption of study product has an effect on acute respiratory infections and/or diarrheal disease.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Acute Respiratory Infection
  • Diarrheal Disease
Intervention  ICMJE
  • Dietary Supplement: Cow's milk
    Powdered Whole Cow's Milk
  • Dietary Supplement: Follow-On Formula
    Powdered Follow-On Formula with added long-chain Polyunsaturated fatty acid, prebiotics, and polysaccharide
Study Arms  ICMJE
  • Placebo Comparator: Cow's Milk
    Powdered Whole Cow's Milk
    Intervention: Dietary Supplement: Cow's milk
  • Experimental: Follow-On Formula
    Powdered Follow-On Formula with added long-chain Polyunsaturated fatty acid, prebiotics, and polysaccharide
    Intervention: Dietary Supplement: Follow-On Formula
Publications * Pontes MV, Ribeiro TC, Ribeiro H, de Mattos AP, Almeida IR, Leal VM, Cabral GN, Stolz S, Zhuang W, Scalabrin DM. Cow's milk-based beverage consumption in 1- to 4-year-olds and allergic manifestations: an RCT. Nutr J. 2016 Feb 27;15:19. doi: 10.1186/s12937-016-0138-0.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: September 8, 2011)
250
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Child 12-48 months of age
  • 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 is receiving predominantly breast-milk
  • 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 length/height < -3 according to World Health Organization criteria
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Months to 48 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01431469
Other Study ID Numbers  ICMJE 6001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mead Johnson Nutrition
Study Sponsor  ICMJE Mead Johnson Nutrition
Collaborators  ICMJE Federal University of Bahia
Investigators  ICMJE Not Provided
PRS Account Mead Johnson Nutrition
Verification Date December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP