Clinical trial NCT00530829: Impact of Home Zinc Treatment for Acute Diarrhea in Children
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diarrhea
Keywords: diarrhea
zinc
oral rehydration therapy
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
Collaborators: name: Kenya Medical Research Institute
name: International Centre for Diarrhoeal Disease Research, Bangladesh
First posted: 2007-09-18
Enrollment: 3000
Sex: ALL
Minimum age (years): 2
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: 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
timeFrame: One year
Secondary outcomes:
measure: 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
timeFrame: one year
Other outcomes:
Locations:
city: Kisumu
country: Kenya
facility: Kenya Medical Research Institute
Study officials:
affiliation: Centers for Disease Control and Prevention
name: Daniel R Feikin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.