NCT00967551

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 143 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 6 Months – 4 Years
• Healthy volunteers: Accepted

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.

Conditions

• Diarrhea
• Respiratory Infection

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Micronutrient Sprinkles with zinc	Daily dose of 1 packet of sprinkles
DIETARY_SUPPLEMENT	Micronutrient sprinkles without zinc	I packet of micronutrient sprinkles without zinc

Timeline

• Start date: 2009-07-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2009-08-28
• Last updated: 2013-04-11
• Results posted: 2013-04-08

Locations

1 site across 1 country: Brazil