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Sponsors and Collaborators: |
International Centre for Diarrhoeal Disease Research, Bangladesh Bill and Melinda Gates Foundation |
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Information provided by: | International Centre for Diarrhoeal Disease Research, Bangladesh |
ClinicalTrials.gov Identifier: | NCT00408356 |
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.
Condition | Intervention | Phase |
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Diarrhoea |
Drug: Zinc |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
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. |
Estimated Enrollment: | 338 |
Study Start Date: | November 2004 |
Study Completion Date: | November 2006 |
Primary Completion Date: | August 2006 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 6 Months to 24 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Bangladesh | |
ICDDR,B. Mirpur Field Site | |
Dhaka, Bangladesh, 1212 |
Study Director: | Amit Saha, MBBS | International Centre for Diarrhoeal Disease Research, Bangladesh |
Responsible Party: | International Centre for Diarrhoeal Diseases Research, Bangladesh ( Dr. Firdausi Qadri ) |
Study ID Numbers: | 2004-017 |
Study First Received: | December 5, 2006 |
Last Updated: | February 19, 2009 |
ClinicalTrials.gov Identifier: | NCT00408356 History of Changes |
Health Authority: | Bangladesh: Ethical Review Committee |
Zinc treatment supplementation Enterotoxigenic E. coli diarrhoea |
Signs and Symptoms Diarrhea Signs and Symptoms, Digestive |
Zinc Trace Elements Micronutrients |
Signs and Symptoms Diarrhea Signs and Symptoms, Digestive Growth Substances Physiological Effects of Drugs |
Zinc Trace Elements Micronutrients Pharmacologic Actions |