Phase 3
N=143
Micronutrient Sprinkles in a Daycare Center
Diarrhea · Respiratory Infection
Bottom Line
View on ClinicalTrials.gov: NCT00967551 ↗Enrolled (actual)
143
Serious AEs
0.0%
Results posted
Apr 2013
Primary outcome: Primary: Proportion of Children of Diarrhea Episodes — 19.1; 14.7 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Micronutrient Sprinkles with zinc (Dietary_supplement); Micronutrient sprinkles without zinc (Dietary_supplement)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- Jul 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Children of Diarrhea Episodes |
19.1; 14.7 | — |
| SECONDARY Proportion of Children With Respiratory Infections |
48.5; 60 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Healthy children attending day care
Exclusion Criteria
- Chronic medical problems including sickle cell disease, congenital heart disease
Data sourced from ClinicalTrials.gov (NCT00967551). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.