Village-randomized clinical trial of home distribution of zinc for treatment of childhood diarrhea in rural Western kenya

Daniel R Feikin, Godfrey Bigogo, Allan Audi, Sherri L Pals, George Aol, Charles Mbakaya, John Williamson, Robert F Breiman, Charles P Larson, Daniel R Feikin, Godfrey Bigogo, Allan Audi, Sherri L Pals, George Aol, Charles Mbakaya, John Williamson, Robert F Breiman, Charles P Larson

Abstract

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.

Trial registration: ClinicalTrials.gov NCT00530829.

Conflict of interest statement

Competing Interests: The authors have declared that no competing interests exist.

Figures

Figure 1. Trial profile.
Figure 1. Trial profile.
Village randomization and number of children enrolled at the initial enrollment in December 2007 and during the ongoing enrollment during the study period from February 2008–March 2009. Children and person-time contribution given for the analysis of clinic-based surveillance and household morbidity surveillance – see methods. PBIDS = Population-based Infectious Disease Surveillance.

References

    1. Bhutta ZA, Bird SM, Black RE, Brown KH, Gardner JM, et al. (2000) Therapeutic effects of oral zinc in acute and persistent diarrhea in children in developing countries: pooled analysis of randomized controlled trials. Am J Clin Nutr 72: 1516–1522.
    1. Bhutta ZA, Black RE, Brown KH, Gardner JM, Gore S, et al. (1999) Prevention of diarrhea and pneumonia by zinc supplementation in children in developing countries: pooled analysis of randomized controlled trials. Zinc Investigators’ Collaborative Group. J Pediatr 135: 689–697.
    1. International Zinc Nutrition Consultive Group (2004) Assessment of the risk of zinc deficiency in populations and options for its control. Food Nutr Bull: S91–S204.
    1. Walker CL, Rudan I, Liu L, Nair H, Theodoratou E, et al. (2013) Global burden of childhood pneumonia and diarrhoea. Lancet 381: 1405–1416.
    1. Lazzerini M, Ronfani L (2012) Oral zinc for treating diarrhoea in children. Cochrane Database Syst Rev 6: CD005436.
    1. WHO/UNICEF (2004) Clinical management of acute diarrhoea. Available: . Accessed 2012 May 16.
    1. Baqui AH, Black RE, El Arifeen S, Yunus M, Chakraborty J, et al. (2002) Effect of zinc supplementation started during diarrhoea on morbidity and mortality in Bangladeshi children: community randomised trial. Bmj 325: 1059.
    1. Bhandari N, Mazumder S, Taneja S, Dube B, Agarwal RC, et al. (2008) Effectiveness of zinc supplementation plus oral rehydration salts compared with oral rehydration salts alone as a treatment for acute diarrhea in a primary care setting: a cluster randomized trial. Pediatrics 121: e1279–1285.
    1. WHO/UNICEF (2013) Integrated global action plan for the prevention and control of pneumonia and diarrhoea. Geneva. Available: . Accessed 2013 May 16.
    1. Larson CP, Koehlmoos TP, Sack DA (2012) Scaling Up of Zinc for Young Children Project T (2012) Scaling up zinc treatment of childhood diarrhoea in Bangladesh: theoretical and practical considerations guiding the SUZY Project. Health Policy Plan 27: 102–114.
    1. Gill CJ, Young M, Schroder K, Carvajal-Velez L, McNabb M, et al. (2013) Bottlenecks, barriers, and solutions: results from multicountry consultations focused on reduction of childhood pneumonia and diarrhoea deaths. Lancet 381: 1487–1498.
    1. Deutscher M, Van Beneden C, Burton D (2012) Putting Surveillance Data into Context: The Role of Health Care Utilization Surveys in Understanding Population Burden of Pneumonia in Developing Countries. J Epidemiology and Public Health in press.
    1. Wilson SE, Ouedraogo CT, Prince L, Ouedraogo A, Hess SY, et al. (2012) Caregiver recognition of childhood diarrhea, care seeking behaviors and home treatment practices in rural Burkina Faso: a cross-sectional survey. PLoS One 7: e33273.
    1. Winch PJ, Gilroy KE, Doumbia S, Patterson AE, Daou Z, et al. (2006) Prescription and administration of a 14-day regimen of zinc treatment for childhood diarrhea in Mali. Am J Trop Med Hyg 74: 880–883.
    1. Feikin DR, Olack B, Bigogo GM, Audi A, Cosmas L, et al. (2011) The burden of common infectious disease syndromes at the clinic and household level from population-based surveillance in rural and urban Kenya. PLoS One 6: e16085.
    1. Phillips-Howard PA, Nahlen BL, Wannemuehler KA, Kolczak MS, ter Kuile FO, et al. (2003) Impact of permethrin-treated bed nets on the incidence of sick child visits to peripheral health facilities. Am J Trop Med Hyg 68: 38–43.
    1. Hamel MJ, Adazu K, Obor D, Sewe M, Vulule J, et al. (2011) A reversal in reductions of child mortality in western Kenya, 2003–2009. Am J Trop Med Hyg 85: 597–605.
    1. Feikin DR, Njenga MK, Bigogo G, Aura B, Aol G, et al. (2013) Viral and bacterial causes of severe acute respiratory illness among children aged less than 5 years in a high malaria prevalence area of western Kenya, 2007–2010. Pediatr Infect Dis J 32: e14–19.
    1. Bigogo G, Audi A, Aura B, Aol G, Breiman RF, et al. (2010) Health-seeking patterns among participants of population-based morbidity surveillance in rural western Kenya: implications for calculating disease rates. Int J Infect Dis 14: e967–973.
    1. Winch PJ, Gilroy KE, Doumbia S, Patterson AE, Daou Z, et al. (2008) Operational issues and trends associated with the pilot introduction of zinc for childhood diarrhoea in Bougouni district, Mali. J Health Popul Nutr 26: 151–162.
    1. Gibson RS, Hess SY, Hotz C, Brown KH (2008) Indicators of zinc status at the population level: a review of the evidence. Br J Nutr 99 Suppl 3 S14–23.
    1. WHO (2008) Integrated Management of Childhood Illness. World Health Organization. Available: . Accessed 2012 May 16.
    1. Rochon J (1998) Application of GEE procedures for sample size calculations in repeated measures experiments. Stat Med 17: 1643–1658.
    1. Feikin DR, Audi A, Olack B, Bigogo GM, Polyak C, et al. (2010) Evaluation of the optimal recall period for disease symptoms in home-based morbidity surveillance in rural and urban Kenya. Int J Epidemiol 39: 450–458.
    1. Kotloff KL, Nataro JP, Blackwelder WC, Nasrin D, Farag TH, et al. (2013) Burden and aetiology of diarrhoeal disease in infants and young children in developing countries (The Global Enterics Multicenter Study): a prospective, case-control study. Lancet. Available: .
    1. Burton DC, Flannery B, Onyango B, Larson C, Alaii J, et al. (2011) Healthcare-seeking behaviour for common infectious disease-related illnesses in rural Kenya: a community-based house-to-house survey. J Health Popul Nutr 29: 61–70.
    1. Kenya National Bureau of Statistics (KNBS) and ICF Macro (2010) Kenya Demographic and Health Survey 2008–09. Calverton, Maryland.
    1. WHO (2010) Guidelines for the treatment of malaria. In: WHO, editor. 2nd ed. Geneva: WHO. Available: . Accessed 2013 May 20.
    1. Marsh DR, Hamer DH, Pagnoni F, Peterson S (2012) Introduction to a special supplement: Evidence for the implementation, effects, and impact of the integrated community case management strategy to treat childhood infection. Am J Trop Med Hyg 87: 2–5.
    1. George A, Young M, Nefdt R, Basu R, Sylla M, et al. (2012) Community health workers providing government community case management for child survival in sub-saharan Africa: who are they and what are they expected to do? Am J Trop Med Hyg 87: 85–91.
    1. Tougher S, Ye Y, Amuasi JH, Kourgueni IA, Thomson R, et al. (2012) Effect of the Affordable Medicines Facility–malaria (AMFm) on the availability, price, and market share of quality-assured artemisinin-based combination therapies in seven countries: a before-and-after analysis of outlet survey data. Lancet 380: 1916–1926.
    1. Brooks WA, Santosham M, Roy SK, Faruque AS, Wahed MA, et al. (2005) Efficacy of zinc in young infants with acute watery diarrhea. Am J Clin Nutr 82: 605–610.
    1. Fischer Walker CL, Bhutta ZA, Bhandari N, Teka T, Shahid F, et al. (2006) Zinc supplementation for the treatment of diarrhea in infants in Pakistan, India and Ethiopia. J Pediatr Gastroenterol Nutr 43: 357–363.
    1. Walker CL, Bhutta ZA, Bhandari N, Teka T, Shahid F, et al. (2007) Zinc during and in convalescence from diarrhea has no demonstrable effect on subsequent morbidity and anthropometric status among infants <6 mo of age. Am J Clin Nutr 85: 887–894.

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