Micronutrient Sprinkles in a Daycare Center

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

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.

Study Overview

• Status: Completed
• Conditions: Diarrhea; Respiratory Infection
• Intervention / Treatment: Dietary supplement: Micronutrient sprinkles without zinc; Dietary supplement: Micronutrient Sprinkles with zinc

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.

• Study Type: Interventional
• Enrollment (Actual): 143
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 3 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy children attending day care

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Micronutrient Sprinkles without zinc; Micronutrient sprinkles without zinc	Dietary supplement: Micronutrient sprinkles without zinc; I packet of micronutrient sprinkles without zinc; Other Names: Micronutrient sprinkles
Experimental: Micronutrient sprinkles with zinc; Micronutrient sprinkles with zinc gluconate	Dietary supplement: Micronutrient Sprinkles with zinc; Daily dose of 1 packet of sprinkles; Other Names: Micronutrient sprinkles

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: Federal University of Bahia
• Investigators: Principal Investigator: Conrad R Cole, MD, MPH, MSc, Emory University; Principal Investigator: Hugo Ribeiro Da Costa, MD, PhD, Universidade Federal da Bahia, Complexo Hospitalar Universitário Professor Edgar Santos, Centro de Pesquisa Fima Lifshitz, Salvador, Bahia, Brazil

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: August 27, 2009
• First Submitted That Met QC Criteria: August 27, 2009
• First Posted (Estimate): August 28, 2009

Study Record Updates

• Last Update Posted (Estimate): April 11, 2013
• Last Update Submitted That Met QC Criteria: April 5, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: Diarrhea; Pneumonia; Acute gastroenteritis; Upper respiratory infections
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Signs and Symptoms, Digestive; Infections; Diarrhea; Respiratory Tract Infections; Physiological Effects of Drugs; Micronutrients; Trace Elements; Zinc
• Other Study ID Numbers: IRB00007903