Micronutrient Sprinkles in a Daycare Center
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Diarrhea Respiratory Infection |
Dietary Supplement: Micronutrient Sprinkles with zinc Dietary Supplement: Micronutrient sprinkles without zinc |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Prevention |
| 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 |
- Proportion of Children of Diarrhea Episodes [ Time Frame: 6 months ] [ Designated as safety issue: No ]Number of children with diarrhea divided by the number of children in the group
- Proportion of Children With Respiratory Infections [ Time Frame: 6 months ] [ Designated as safety issue: No ]Number of children with respiratory infections divided by the total number of children in the group
| Enrollment: | 143 |
| Study Start Date: | July 2009 |
| Study Completion Date: | July 2012 |
| Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Micronutrient Sprinkles without zinc
Micronutrient sprinkles without zinc
|
Dietary Supplement: Micronutrient sprinkles without zinc
I packet of micronutrient sprinkles without zinc
Other Name: 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 Name: Micronutrient 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.
Eligibility| Ages Eligible for Study: | 6 Months to 4 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Healthy children attending day care
Exclusion Criteria:
- Chronic medical problems including sickle cell disease, congenital heart disease
Contacts and Locations| Brazil | |
| Universidade Federal da Bahia, Complexo Hospitalar Universitário Professor Edgar Santos, Centro de Pesquisa Fima Lifshitz | |
| Salvador, Bahia, Brazil | |
| 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 |
More Information
No publications provided
| Responsible Party: | Conrad R. Cole, Associate Professor, Emory University |
| ClinicalTrials.gov Identifier: | NCT00967551 History of Changes |
| Other Study ID Numbers: | IRB00007903 |
| Study First Received: | August 27, 2009 |
| Results First Received: | January 24, 2013 |
| Last Updated: | April 5, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Emory University:
|
Diarrhea Pneumonia Upper respiratory infections Acute gastroenteritis |
Additional relevant MeSH terms:
|
Diarrhea Respiratory Tract Infections Signs and Symptoms, Digestive Signs and Symptoms Infection Respiratory Tract Diseases |
Micronutrients Zinc Trace Elements Growth Substances Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013