CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 143 enrolled
Drug / intervention
Micronutrient Sprinkles with zinc +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00967551
NCT00967551Phase 3Completed

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

Emory University·interventional·Posted Aug 28, 2009·Updated Apr 11, 2013

In Brief

A Phase 3 clinical trial evaluating Micronutrient Sprinkles with zinc and Micronutrient sprinkles without zinc for Diarrhea and Respiratory Infection. Completed, enrolled 143 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBrazil

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 28, 2009
Enrollment StartJul 1, 2009
Primary CompletionJul 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 16.8 years ago

Interventions

Micronutrient Sprinkles with zincdietary

Daily dose of 1 packet of sprinkles

Micronutrient sprinkles without zincdietary

I packet of micronutrient sprinkles without zinc