NCT00530829

Impact of Home Zinc Treatment for Acute Diarrhea in Children

Clinical Effectiveness and Preventive Impact of Home Zinc Treatment for Acute Diarrhea in Children: A Cluster-randomized Field Trial in Rural Western Kenya

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,000 (actual)
• Sponsor: Centers for Disease Control and Prevention · Federal
• Sex: All
• Age: 2 Months – 4 Years
• Healthy volunteers: Accepted

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.

Conditions

• Diarrhea

Interventions

Type	Name	Description
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

Timeline

• Start date: 2007-10-01
• Primary completion: 2009-04-01
• Completion: 2009-04-01
• First posted: 2007-09-18
• Last updated: 2010-03-09

Locations

1 site across 1 country: Kenya