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OpenTrials
Completed

NCT Number: NCT00967551

Micronutrient Sprinkles in a Daycare Center

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.

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Key information

Age range

6 month–4 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

Salvador, Estado de Bahia, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy children attending day care

Exclusion criteria

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

Treatment and study plan

Micronutrient Sprinkles with zinc

Dietary Supplement

Daily dose of 1 packet of sprinkles

Other names: Micronutrient sprinkles

Micronutrient sprinkles without zinc

Dietary Supplement

I packet of micronutrient sprinkles without zinc

Other names: Micronutrient sprinkles

Primary outcomes

  1. Proportion of Children of Diarrhea Episodes

    Time frame: 6 months

    Number of children with diarrhea divided by the number of children in the group

Secondary outcomes

  1. Proportion of Children With Respiratory Infections

    Time frame: 6 months

    Number of children with respiratory infections divided by the total number of children in the group

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • Federal University of Bahia

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Aug 28, 2009
Registry last updated
Apr 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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