Impact of Home Zinc Treatment for Acute Diarrhea in Children

Study Description

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Brief Summary:

Background. Zinc deficiency is common in Africa. It has been shown in Asia that zinc as treatment for diarrhea can shorten the course of episodes of diarrhea, as well as prevent future episodes. The use of zinc at home to treat diarrhea in an African setting, where malaria, HIV and malnutrition are common, has not been well-studied.

Objective. To evaluate if zinc treatment for diarrhea given at home in Kenyan children will decrease the community prevalence of diarrhea more than zinc given only in the clinic Work planned. We propose to do a community-randomized intervention study of 10 days of dispersible zinc tablets given in the home, in addition to ORS, to treat diarrhea in children under-5 years of age living in a rural part of Bondo District. The comparison group will be children who receive zinc and ORS in the clinic only. The primary outcome will be a comparison of the prevalence of diarrhea in home zinc versus nonhome zinc villages. Secondary outcomes will be the incidence of repeat episodes of diarrhea, the duration of diarrheal illness, the prevalence of acute respiratory infection, and the effect of malaria infection on treatment with zinc. Thirty-three villages (approximately 1300 children) will be enrolled and children will be followed for 1 year.

Significance of results. If this study shows zinc given at home to be effective, this might be considered by the Kenyan MOH as an essential component of the treatment of diarrhea in children at the community level.

Condition or disease	Intervention/treatment	Phase
Diarrhea	Drug: zinc	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	3000 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Clinical Effectiveness and Preventive Impact of Home Zinc Treatment for Acute Diarrhea in Children: A Cluster-randomized Field Trial in Rural Western Kenya
Study Start Date :	October 2007
Actual Primary Completion Date :	April 2009
Actual Study Completion Date :	April 2009

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: 1; Mothers recieve a blister pack of zinc tablets in home every two months for use when child in home under 5 years has diarrhea. ORS satchets also given. Instructions on when and how to use zinc and ORS and when to take child in clinic are given by community health worker. Zinc will also be given in clinic if child visits clinic with diarrhea and has not yet started zinc at home.	Drug: zinc; 10 day blister pack of 20 mg zinc disperable tablets, 1 tablet qd for children 6 months to 4 years, 1/2 tablet qd for children 2-5 months
Active Comparator: 2; Mothers recieve ORS satchets at home every two months for use when child in home under 5 years has diarrhea. Instructions on when and how to use ORS and when to take child in clinic are given by community health worker. Zinc will be given in clinic if child visits clinic with diarrhea.	Drug: zinc; 10 day blister pack of 20 mg zinc disperable tablets, 1 tablet qd for children 6 months to 4 years, 1/2 tablet qd for children 2-5 months

Outcome Measures

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Primary Outcome Measures :

1. To assess if access to zinc treatment for diarrhea in the home in addition to zinc treatment of diarrhea in the clinic leads to a greater reduction in the prevalence of diarrhea than giving zinc for treatment of diarrhea in the clinic only [ Time Frame: One year ]

Secondary Outcome Measures :

1. To assess if access to zinc treatment for diarrhea in the home in addition to zinc treatment of diarrhea in the clinic decreases the likelihood of recurrent diarrhea episodes, acute respiratory infections, and antimicrobial use [ Time Frame: one year ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	2 Months to 4 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

• All children 2 to 59 months of age in households within 33 selected villages

Exclusion Criteria:

• Children under 2 months of age will not be eligible for enrollment, until they reach 2 months of age as the role of zinc has not been well-studied in neonates. Children of parents who do not give written informed consent for their participation will not be enrolled.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Kenya
Kenya Medical Research Institute
Kisumu, Kenya

Sponsors and Collaborators

Centers for Disease Control and Prevention

Kenya Medical Research Institute

International Centre for Diarrhoeal Disease Research, Bangladesh

Investigators

Principal Investigator:	Daniel R Feikin, MD	Centers for Disease Control and Prevention

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Document WHO/FCH/CAH/04.7 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Feikin DR, Bigogo G, Audi A, Pals SL, Aol G, Mbakaya C, Williamson J, Breiman RF, Larson CP. Village-randomized clinical trial of home distribution of zinc for treatment of childhood diarrhea in rural Western kenya. PLoS One. 2014 May 16;9(5):e94436. doi: 10.1371/journal.pone.0094436. eCollection 2014.

Responsible Party:	Daniel Feikin, Medical epidemiologist, CDC
ClinicalTrials.gov Identifier:	NCT00530829 History of Changes
Other Study ID Numbers:	CDC-NCPDCID-4678
First Posted:	September 18, 2007
Last Update Posted:	March 9, 2010
Last Verified:	March 2010

Keywords provided by Centers for Disease Control and Prevention:

diarrhea; zinc; oral rehydration therapy

Additional relevant MeSH terms:

Diarrhea; Signs and Symptoms, Digestive; Signs and Symptoms; Zinc	Trace Elements; Micronutrients; Growth Substances; Physiological Effects of Drugs