Immunological and Clinical Responses to Zinc in Children With Diarrhoea
Status:
Completed
Trial end date:
2006-11-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
International Centre for Diarrhoeal Disease Research, Bangladesh