Micronutrient Sprinkles in a Daycare Center

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Diarrhea, Respiratory Infection

Intervention / Treatment
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* Dietary Supplement: Micronutrient Sprinkles with zinc
* Dietary Supplement: Micronutrient sprinkles without zinc


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy children attending day care Exclusion Criteria: Chronic medical problems including sickle cell disease, congenital heart disease

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 4 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Micronutrient Sprinkles without zinc<br>Micronutrient sprinkles without zinc | Dietary Supplement: Micronutrient sprinkles without zinc<br>* I packet of micronutrient sprinkles without zinc<br>* Other names: Micronutrient sprinkles;|
| Experimental: Micronutrient sprinkles with zinc<br>Micronutrient sprinkles with zinc gluconate | Dietary Supplement: Micronutrient Sprinkles with zinc<br>* Daily dose of 1 packet of sprinkles<br>* Other names: Micronutrient sprinkles;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Children of Diarrhea Episodes | Number of children with diarrhea divided by the number of children in the group | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Children With Respiratory Infections | Number of children with respiratory infections divided by the total number of children in the group | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diarrhea, Pneumonia, Upper respiratory infections, Acute gastroenteritis