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Micronutrient Sprinkles in a Daycare Center

Primary Purpose

Diarrhea, Respiratory Infection

Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Micronutrient Sprinkles with zinc
Micronutrient sprinkles without zinc
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diarrhea focused on measuring Diarrhea, Pneumonia, Upper respiratory infections, Acute gastroenteritis

Eligibility Criteria

6 Months - 4 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy children attending day care

Exclusion Criteria:

  • Chronic medical problems including sickle cell disease, congenital heart disease

Sites / Locations

  • Universidade Federal da Bahia, Complexo Hospitalar Universitário Professor Edgar Santos, Centro de Pesquisa Fima Lifshitz

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Micronutrient Sprinkles without zinc

Micronutrient sprinkles with zinc

Arm Description

Micronutrient sprinkles without zinc

Micronutrient sprinkles with zinc gluconate

Outcomes

Primary Outcome Measures

Proportion of Children of Diarrhea Episodes
Number of children with diarrhea divided by the number of children in the group

Secondary Outcome Measures

Proportion of Children With Respiratory Infections
Number of children with respiratory infections divided by the total number of children in the group

Full Information

First Posted
August 27, 2009
Last Updated
April 5, 2013
Sponsor
Emory University
Collaborators
Federal University of Bahia
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1. Study Identification

Unique Protocol Identification Number
NCT00967551
Brief Title
Micronutrient Sprinkles in a Daycare Center
Official Title
The Impact of the Use of Zinc Supplementation and Other Micronutrients on the Occurence of Diarrhea Diseases and Respiratory Infections in Children of Daycare Centers
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
Federal University of Bahia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Diarrheal diseases are a major cause of morbidity and mortality globally in children less than 5 years of age. Prolonged diarrhea, recurrent infections and growth failure in developing countries are usually a consequence of micronutrient deficiencies including zinc. The primary aims of the proposed study are to evaluate the effect of the use of multiple micronutrient sprinkles including zinc on compliance of supplement use and the incidence of recurrent diarrheal and respiratory illnesses. The proposed study will be conducted at the Fima Lifshitz Metabolic Research Center, Department of Pediatrics, Universidade Federal Da Bahia, Salvador-Bahia, Brazil over a period of 18 months. This is a double-blind placebo-controlled trial involving the use of 2 types of micronutrient sprinkles in a group of 120 children who attend a day care center in Salvador, Bahia. They will be randomized into 2 groups of 60 children each. The intervention group will receive sprinkles containing zinc while the control group will receive micronutrient sprinkles without zinc. The primary outcome variables of interest are zinc status, stool zinc losses and diarrhea duration. Both groups of infants will be monitored at monthly intervals for an initial duration of 180 days for zinc status, diarrhea episodes, respiratory illness and growth. This study will allow for the establishment of a cohort of children who will be monitored in a micronutrient supplementation trial using sprinkles.
Detailed Description
The proposed study will be conducted at the Fima Lifshitz Metabolic Research Center, Department of Pediatrics, Universidade Federal Da Bahia, Salvador-Bahia, Brazil over a period of 18 months. This is a double-blind placebo-controlled trial involving the use of 2 types of micronutrient sprinkles in a group of 120 children who attend a day care center in Salvador, Bahia. They will be randomized into 2 groups of 60 children each. The intervention group will receive sprinkles containing zinc while the control group will receive micronutrient sprinkles without zinc. The primary outcome variables of interest are zinc status, stool zinc losses and diarrhea duration. Both groups of infants will be monitored at monthly intervals for an initial duration of 180 days for zinc status, diarrhea episodes, respiratory illness and growth. This study will allow for the establishment of a cohort of children who will be monitored in a micronutrient supplementation trial using sprinkles.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhea, Respiratory Infection
Keywords
Diarrhea, Pneumonia, Upper respiratory infections, Acute gastroenteritis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
143 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Micronutrient Sprinkles without zinc
Arm Type
Active Comparator
Arm Description
Micronutrient sprinkles without zinc
Arm Title
Micronutrient sprinkles with zinc
Arm Type
Experimental
Arm Description
Micronutrient sprinkles with zinc gluconate
Intervention Type
Dietary Supplement
Intervention Name(s)
Micronutrient Sprinkles with zinc
Other Intervention Name(s)
Micronutrient sprinkles
Intervention Description
Daily dose of 1 packet of sprinkles
Intervention Type
Dietary Supplement
Intervention Name(s)
Micronutrient sprinkles without zinc
Other Intervention Name(s)
Micronutrient sprinkles
Intervention Description
I packet of micronutrient sprinkles without zinc
Primary Outcome Measure Information:
Title
Proportion of Children of Diarrhea Episodes
Description
Number of children with diarrhea divided by the number of children in the group
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Proportion of Children With Respiratory Infections
Description
Number of children with respiratory infections divided by the total number of children in the group
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy children attending day care Exclusion Criteria: Chronic medical problems including sickle cell disease, congenital heart disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Conrad R Cole, MD, MPH, MSc
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hugo Ribeiro Da Costa, MD, PhD
Organizational Affiliation
Universidade Federal da Bahia, Complexo Hospitalar Universitário Professor Edgar Santos, Centro de Pesquisa Fima Lifshitz, Salvador, Bahia, Brazil
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade Federal da Bahia, Complexo Hospitalar Universitário Professor Edgar Santos, Centro de Pesquisa Fima Lifshitz
City
Salvador
State/Province
Bahia
Country
Brazil

12. IPD Sharing Statement

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Micronutrient Sprinkles in a Daycare Center

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