Immunological and Clinical Responses to Zinc in Children With Diarrhoea
Condition: Diarrhoea
MeSH terms: Diarrhea
Study type: Interventional
Phase: Phase 3

Summary: 
      Zinc deficiency has been found to be widespread among children in developing
      countries.Clinical and field studies have consistently observed an association between zinc
      deficiency and higher rates of infectious diseases, including skin infections, diarrhea,
      respiratory infections, malaria, and delayed wound healing. Based upon the impact of zinc
      deficiency on diarrheal disease alone, it is estimated correction of this deficiency could
      save 450,000 under-five deaths annually. What is the physiological explanation for this? Zinc
      has been identified to play critical roles in metallo-enzymes, poly-ribosomes, the cell
      membrane, and cellular function, leading to the understanding that it also plays a central
      role in cellular growth and in the function of the immune system. With zinc deficiency
      epithelial barriers are compromised and multiple components of the immune system malfunction.
      The obvious conclusion is that zinc deficiency results in diminished immunological competence
      that in turn leads to an increased risk for infectious diseases and greater severity of
      illnesses. Whether this is the case requires substantiation. A related, but more pragmatic
      question is the value added of zinc supplementation in addition to zinc treatment. The
      scale-up strategy being pursued in Bangladesh is to provide zinc for 10 days as a treatment
      at the time of a diarrhea episode. This is in accordance with recently revised WHO
      recommendations for the treatment of childhood diarrhea (WHO, in press). Can we conclude
      there is no or minimal value added to continuing zinc as a dietary supplement in zinc
      deficient children following an acute episode? If there is added benefit, can this be
      explained by improvement in zinc levels and/or immune function? The aims of this study
      include:1. In children six to twenty-four months of age with an acute episode of diarrhea
      attributable to enterotoxigenic E. coli (ETEC), to describe the innate and adaptive immune
      response to zinc and to relate changes in immune function or zinc status to the occurrence of
      repeat infectious illnesses over a 9 month period of observation. 2a. In children six to
      twenty-four months of age with an acute episode of diarrhea with enterotoxigenic E. coli
      (ETEC), and other non-ETEC diarrhea, to determine the value added of zinc supplementation
      following treatment in terms of the future occurrence of ACD, ARI, and impetigo and 2b. to
      assess the impact of zinc supplementation on health services utilization and household
      expenditures for ACD, ARI and impetigo.
    


Intervention name(s): Zinc
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Zinc treatment; supplementation; Enterotoxigenic E. coli; diarrhoea