Micronutrient Sprinkles in a Daycare Center

NCT ID: NCT00967551

Last Updated: 2013-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 143 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2012-07-31

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.

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.

Conditions

Diarrhea; Respiratory Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Micronutrient Sprinkles without zinc

Micronutrient sprinkles without zinc

Group Type: ACTIVE_COMPARATOR

Micronutrient sprinkles without zinc

Intervention Type: DIETARY_SUPPLEMENT

I packet of micronutrient sprinkles without zinc

Micronutrient sprinkles with zinc

Micronutrient sprinkles with zinc gluconate

Group Type: EXPERIMENTAL

Micronutrient Sprinkles with zinc

Intervention Type: DIETARY_SUPPLEMENT

Daily dose of 1 packet of sprinkles

Interventions

Micronutrient Sprinkles with zinc

Daily dose of 1 packet of sprinkles

Intervention Type: DIETARY_SUPPLEMENT

Micronutrient sprinkles without zinc

I packet of micronutrient sprinkles without zinc

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Micronutrient sprinkles; Micronutrient sprinkles

Eligibility Criteria

Inclusion Criteria

• Healthy children attending day care

Exclusion Criteria

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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 4 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Federal University of Bahia

OTHER

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Conrad R. Cole

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Conrad R Cole, MD, MPH, MSc

Role: PRINCIPAL_INVESTIGATOR

Emory University

Hugo Ribeiro Da Costa, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Salvador, Estado de Bahia, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 36994923 (View on PubMed)

Other Identifiers

IRB00007903

Identifier Type: -

Identifier Source: org_study_id