Impact of Home Zinc Treatment for Acute Diarrhea in Children

Diarrhea Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00530829
• Other study ID #: CDC-NCPDCID-4678
• Status: Completed
• Phase: Phase 3
• First received: September 17, 2007
• Last updated: March 8, 2010
• Start date: October 2007
• Est. completion date: April 2009

Study information

• Verified date: March 2010
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3000
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Months to 4 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diarrhea

Intervention

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

Locations

Country	Name	City	State
Kenya	Kenya Medical Research Institute	Kisumu

Sponsors (3)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention	International Centre for Diarrhoeal Disease Research, Bangladesh, Kenya Medical Research Institute

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		One year	Yes
Secondary	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		one year	Yes

External Links

•   Document WHO/FCH/CAH/04.7