Back to resultsEfficacy and Tolerance of a Follow-On Formula Fed to Children From 12-48 Months of Age in Salvador, Bahia, Brazil
Primary Purpose
Acute Respiratory Infection, Diarrheal Disease
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Cow's milk
Follow-On Formula
Sponsored by
About this trial
This is an interventional prevention trial for Acute Respiratory Infection
Eligibility Criteria
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
Sites / Locations
- Universidade Federal da Bahia, Hospital Universitário Prof. Edgard Santos Complexo HUPES, Centro Pediátrico Professor Hossanah Oliveira, Centro da Pesquisas Fima Lifshitz, Rua Augusto Viana s/n Canela
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Cow's Milk
Follow-On Formula
Arm Description
Powdered Whole Cow's Milk
Powdered Follow-On Formula with added long-chain Polyunsaturated fatty acid, prebiotics, and polysaccharide
Outcomes
Primary Outcome Measures
Episodes of acute respiratory infections and diarrheal disease
Secondary Outcome Measures
Occurrence of allergic manifestations
Systemic antibiotic use
Duration of acute respiratory infection and diarrheal disease
Changes in stool patterns
Fecal and serum immune markers
Serum Ferritin and Zinc status
Incidence of stool parasites
Growth
Incidence of adverse events
The incidence of any adverse event for each participant
Acceptance of study product
Acceptance of study product based on quantity consumed
Full Information
NCT ID
NCT01431469
First Posted
August 31, 2011
Last Updated
December 5, 2012
Sponsor
Mead Johnson Nutrition
Collaborators
Federal University of Bahia
1. Study Identification
Unique Protocol Identification Number
NCT01431469
Brief Title
Efficacy and Tolerance of a Follow-On Formula Fed to Children From 12-48 Months of Age in Salvador, Bahia, Brazil
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mead Johnson Nutrition
Collaborators
Federal University of Bahia
4. Oversight
5. Study Description
Brief Summary
The purpose is to determine if the consumption of study product has an effect on acute respiratory infections and/or diarrheal disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Infection, Diarrheal Disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cow's Milk
Arm Type
Placebo Comparator
Arm Description
Powdered Whole Cow's Milk
Arm Title
Follow-On Formula
Arm Type
Experimental
Arm Description
Powdered Follow-On Formula with added long-chain Polyunsaturated fatty acid, prebiotics, and polysaccharide
Intervention Type
Dietary Supplement
Intervention Name(s)
Cow's milk
Intervention Description
Powdered Whole Cow's Milk
Intervention Type
Dietary Supplement
Intervention Name(s)
Follow-On Formula
Intervention Description
Powdered Follow-On Formula with added long-chain Polyunsaturated fatty acid, prebiotics, and polysaccharide
Primary Outcome Measure Information:
Title
Episodes of acute respiratory infections and diarrheal disease
Time Frame
28 weeks
Secondary Outcome Measure Information:
Title
Occurrence of allergic manifestations
Time Frame
28 weeks
Title
Systemic antibiotic use
Time Frame
28 weeks
Title
Duration of acute respiratory infection and diarrheal disease
Time Frame
28 weeks
Title
Changes in stool patterns
Time Frame
28 weeks
Title
Fecal and serum immune markers
Time Frame
28 weeks
Title
Serum Ferritin and Zinc status
Time Frame
28 weeks
Title
Incidence of stool parasites
Time Frame
28 weeks
Title
Growth
Time Frame
28 weeks
Title
Incidence of adverse events
Description
The incidence of any adverse event for each participant
Time Frame
28 weeks
Title
Acceptance of study product
Description
Acceptance of study product based on quantity consumed
Time Frame
28 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
48 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Universidade Federal da Bahia, Hospital Universitário Prof. Edgard Santos Complexo HUPES, Centro Pediátrico Professor Hossanah Oliveira, Centro da Pesquisas Fima Lifshitz, Rua Augusto Viana s/n Canela
City
Salvador
State/Province
Bahia
ZIP/Postal Code
CEP 401 10-060
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
26920136
Citation
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.
Results Reference
derived
Learn more about this trial
Efficacy and Tolerance of a Follow-On Formula Fed to Children From 12-48 Months of Age in Salvador, Bahia, Brazil
We'll reach out to this number within 24 hrs