Immunological and Clinical Responses to Zinc in Children With Diarrhoea

This study has been completed.
Sponsor:
Collaborator:
Bill and Melinda Gates Foundation
Information provided by:
International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier:
NCT00408356
First received: December 5, 2006
Last updated: February 19, 2009
Last verified: February 2009
  Purpose

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
Diarrhoea
Drug: Zinc
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by International Centre for Diarrhoeal Disease Research, Bangladesh:

Primary Outcome Measures:
  • To evaluate innate and adaptive immune response.
  • Future occurrence of acute diarrhoea, ARI and impetigo.

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)
  Eligibility

Ages Eligible for Study:   6 Months to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children 6-24 months of age with acute childhood diarrheal illness.

Exclusion Criteria:

  • Severe dehydration, suspected cholera or pneumonia, chronic illness, bipedal edema (seriously ill children will be referred to ICDDR,B/Shishu Hospital).
  • The child is currently receiving zinc (as a treatment or supplement)
  • Wt/length, z-score below -3 (these children will be referred to ICDDR,B/ Shishu Hospital)
  • Already participating in another study involving nutritional or therapeutic interventions
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00408356

Locations
Bangladesh
ICDDR,B. Mirpur Field Site
Dhaka, Bangladesh, 1212
Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
Bill and Melinda Gates Foundation
Investigators
Study Director: Amit Saha, MBBS International Centre for Diarrhoeal Disease Research, Bangladesh
  More Information

No publications provided by International Centre for Diarrhoeal Disease Research, Bangladesh

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Firdausi Qadri, International Centre for Diarrhoeal Diseases Research, Bangladesh
ClinicalTrials.gov Identifier: NCT00408356     History of Changes
Other Study ID Numbers: 2004-017
Study First Received: December 5, 2006
Last Updated: February 19, 2009
Health Authority: Bangladesh: Ethical Review Committee

Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:
Zinc treatment
supplementation
Enterotoxigenic E. coli
diarrhoea

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Zinc
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014