Micronutrient Sprinkles in a Daycare Center

Phase 3

Completed

• Conditions: Diarrhea; Respiratory Infection
• Interventions: Dietary Supplement: Micronutrient sprinkles without zinc; Dietary Supplement: Micronutrient Sprinkles with zinc

• Registration Number: NCT00967551
• Lead Sponsor: Emory University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-08-27
• Study First Submitted QC: 2009-08-27
• Study First Posted: 2009-08-28
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Results First Submitted: 2013-01-24
• Results First Submitted QC: 2013-03-01
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-05
• Results First Posted: 2013-04-08
• Last Update Posted: 2013-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 143

Inclusion Criteria

• Healthy children attending day care

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Micronutrient Sprinkles without zinc	Micronutrient sprinkles without zinc	Micronutrient sprinkles without zinc
Micronutrient sprinkles with zinc	Micronutrient Sprinkles with zinc	Micronutrient sprinkles with zinc gluconate

Primary Outcome Measures

Name	Time	Method
Proportion of Children of Diarrhea Episodes	6 months	Number of children with diarrhea divided by the number of children in the group

Secondary Outcome Measures

Name	Time	Method
Proportion of Children With Respiratory Infections	6 months	Number of children with respiratory infections divided by the total number of children in the group

Trial Locations

Locations (1)

Universidade Federal da Bahia, Complexo Hospitalar Universitário Professor Edgar Santos, Centro de Pesquisa Fima Lifshitz; 🇧🇷 Salvador, Bahia, Brazil