Micronutrient Sprinkles in a Daycare Center

This study has been completed.
Sponsor:
Collaborator:
Federal University of Bahia
Information provided by (Responsible Party):
Conrad R. Cole, Emory University
ClinicalTrials.gov Identifier:
NCT00967551
First received: August 27, 2009
Last updated: April 5, 2013
Last verified: April 2013
  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

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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
Criteria

Inclusion Criteria:

  • Healthy children attending day care

Exclusion Criteria:

  • Chronic medical problems including sickle cell disease, congenital heart disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00967551

Locations
Brazil
Universidade Federal da Bahia, Complexo Hospitalar Universitário Professor Edgar Santos, Centro de Pesquisa Fima Lifshitz
Salvador, Bahia, Brazil
Sponsors and Collaborators
Emory University
Federal University of Bahia
Investigators
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:
Communicable Diseases
Diarrhea
Infection
Respiratory Tract Infections
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Digestive
Micronutrients
Trace Elements
Zinc
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 29, 2014