Micronutrient Sprinkles in a Daycare Center

NCT00967551 | Completed Phase 3 Results

• 1 other identifier: IRB00007903
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diarrhea; Respiratory Infection

Keywords

Diarrhea; Pneumonia; Upper respiratory infections; Acute gastroenteritis

Outcome Measures

Primary Outcomes (1)

• Proportion of Children of Diarrhea Episodes

  Number of children with diarrhea divided by the number of children in the group

  6 months

Secondary Outcomes (1)

• Proportion of Children With Respiratory Infections

  6 months

Study Arms (2)

Micronutrient Sprinkles without zinc

ACTIVE COMPARATOR

Micronutrient sprinkles without zinc

Dietary Supplement: Micronutrient sprinkles without zinc

Micronutrient sprinkles with zinc

EXPERIMENTAL

Micronutrient sprinkles with zinc gluconate

Dietary Supplement: Micronutrient Sprinkles with zinc

Interventions

Micronutrient Sprinkles with zinc DIETARY_SUPPLEMENT

Daily dose of 1 packet of sprinkles

Also known as: Micronutrient sprinkles

Micronutrient sprinkles with zinc

Micronutrient sprinkles without zinc DIETARY_SUPPLEMENT

I packet of micronutrient sprinkles without zinc

Also known as: Micronutrient sprinkles

Micronutrient Sprinkles without zinc

Eligibility Criteria

• Age: 6 Months - 4 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy children attending day care

You may not qualify if:

• Chronic medical problems including sickle cell disease, congenital heart disease

Sponsors & Collaborators

• Emory University: lead
• Federal University of Bahia: collaborator

Study Sites (1)

Universidade Federal da Bahia, Complexo Hospitalar Universitário Professor Edgar Santos, Centro de Pesquisa Fima Lifshitz

Salvador, Estado de Bahia, Brazil

Location

Related Publications (1)

• Imdad A, Rogner J, Sherwani RN, Sidhu J, Regan A, Haykal MR, Tsistinas O, Smith A, Chan XHS, Mayo-Wilson E, Bhutta ZA. Zinc supplementation for preventing mortality, morbidity, and growth failure in children aged 6 months to 12 years. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD009384. doi: 10.1002/14651858.CD009384.pub3.

  PMID: 36994923 DERIVED

MeSH Terms

Conditions

Diarrhea; Respiratory Tract Infections; Pneumonia

Interventions

Zinc

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infections; Respiratory Tract Diseases; Lung Diseases

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Results Point of Contact

• Title: Hugo Costa-Ribeiro
• Organization: Hospital Universitário Professor Edgard Santos, Universidade Federal da Bahia, Salvador, Bahia, Brasil

hugocrj@ufba.br

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 27, 2009
• First Posted: August 28, 2009
• Study Start: July 1, 2009
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: April 11, 2013
• Results First Posted: April 8, 2013

Record last verified: 2013-04

Locations

BR (1)