Ignite Creation Date:
2024-05-05 @ 5:10 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00408356
Status:
COMPLETED
Last Update Posted:
2009-02-20
First Post:
2006-12-05
Brief Title:
Immunological and Clinical Responses to Zinc in Children With Diarrhoea
Sponsor:
International Centre for Diarrhoeal Disease Research Bangladesh
Organization:
International Centre for Diarrhoeal Disease Research Bangladesh
Study Overview
Official Title:
Immunological and Clinical Responses to Zinc A Randomized Double-Blind Trial of Zinc Treatment vs Zinc Treatment Plus Daily Supplementation for 3 Months Among Children Under 2 Years of Age With an Acute Diarrheal Illness
Status:
COMPLETED
Status Verified Date:
2009-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Zinc deficiency has been found to be widespread among children in developing countriesClinical 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 450000 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 andor immune function The aims of this study include1 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None