Micronutrient Sprinkles in a Daycare Center

Diarrhea Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00967551
• Other study ID #: IRB00007903
• Status: Completed
• Phase: Phase 3
• First received: August 27, 2009
• Last updated: April 5, 2013
• Start date: July 2009
• Est. completion date: July 2012

Study information

• Verified date: April 2013
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 4 Years

Eligibility

Inclusion Criteria:

• Healthy children attending day care

Exclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diarrhea
• Infection
• Respiratory Infection
• Respiratory Tract Infections

Intervention

Dietary Supplement:
• Micronutrient Sprinkles with zinc
Daily dose of 1 packet of sprinkles
• Micronutrient sprinkles without zinc
I packet of micronutrient sprinkles without zinc

Locations

Country	Name	City	State
Brazil	Universidade Federal da Bahia, Complexo Hospitalar Universitário Professor Edgar Santos, Centro de Pesquisa Fima Lifshitz	Salvador	Bahia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	Federal University of Bahia

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Children of Diarrhea Episodes	Number of children with diarrhea divided by the number of children in the group	6 months	No
Secondary	Proportion of Children With Respiratory Infections	Number of children with respiratory infections divided by the total number of children in the group	6 months	No