Village-randomized clinical trial of home distribution of zinc for treatment of childhood diarrhea in rural Western kenya.
BACKGROUND
Zinc treatment shortens diarrhea episodes and can prevent future episodes. In rural Africa, most children with diarrhea are not brought to health facilities. In a village-randomized trial in rural Kenya, we assessed if zinc treatment might have a community-level preventive effect on diarrhea incidence if available at home versus only at health facilities.


METHODS
We randomized 16 Kenyan villages (1,903 eligible children) to receive a 10-day course of zinc and two oral rehydration solution (ORS) sachets every two months at home and 17 villages (2,241 eligible children) to receive ORS at home, but zinc at the health-facility only. Children's caretakers were educated in zinc/ORS use by village workers, both unblinded to intervention arm. We evaluated whether incidence of diarrhea and acute lower respiratory illness (ALRI) reported at biweekly home visits and presenting to clinic were lower in zinc villages, using poisson regression adjusting for baseline disease rates, distance to clinic, and children's age.


RESULTS
There were no differences between village groups in diarrhea incidence either reported at the home or presenting to clinic. In zinc villages (1,440 children analyzed), 61.2% of diarrheal episodes were treated with zinc, compared to 5.4% in comparison villages (1,584 children analyzed, p<0.0001). There were no differences in ORS use between zinc (59.6%) and comparison villages (58.8%). Among children with fever or cough without diarrhea, zinc use was low (<0.5%). There was a lower incidence of reported ALRI in zinc villages (adjusted RR 0.68, 95% CI 0.46-0.99), but not presenting at clinic.


CONCLUSIONS
In this study, home zinc use to treat diarrhea did not decrease disease rates in the community. However, with proper training, availability of zinc at home could lead to more episodes of pediatric diarrhea being treated with zinc in parts of rural Africa where healthcare utilization is low.


BACKGROUND
ClinicalTrials.gov NCT00530829.
International Emerging Infections Program, Centers for Disease Control and Prevention Kisumu, Kenya.
Daniel R
DR
Feikin
International Emerging Infections Program, Centers for Disease Control and Prevention Kisumu, Kenya; Kenya Medical Research Institute, Nairobi, Kenya.
Godfrey
G
Bigogo
International Emerging Infections Program, Centers for Disease Control and Prevention Kisumu, Kenya; Kenya Medical Research Institute, Nairobi, Kenya.
Allan
A
Audi
Division of Global HIV/AIDS, United States Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.
Sherri L
SL
Pals
International Emerging Infections Program, Centers for Disease Control and Prevention Kisumu, Kenya; Kenya Medical Research Institute, Nairobi, Kenya.
George
G
Aol
Kenya Medical Research Institute, Nairobi, Kenya.
Charles
C
Mbakaya
Center for Global Health, United States Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.
John
J
Williamson
International Emerging Infections Program, Centers for Disease Control and Prevention Kisumu, Kenya.
Robert F
RF
Breiman
International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka, Bangladesh; Department of Pediatrics, University of British Columbia, Vancouver, Canada.
Charles P
CP
Larson
D002648:Child; D003967:Diarrhea / Q000188:drug therapy*; D005440:Fluid Therapy / Q000379:methods / Q000706:statistics & numerical data*; D018718:Home Infusion Therapy / Q000379:methods / Q000706:statistics & numerical data*; D006801:Humans; D007630:Kenya; D012044:Regression Analysis; D012424:Rural Population; D015032:Zinc / Q000627:therapeutic use*
D015032:Zinc