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CompletedNCT00408356Updated Feb 20, 2009

Immunological and Clinical Responses to Zinc in Children With Diarrhoea

A Phase 3 interventional study of Zinc in Diarrhoea, sponsored by International Centre for Diarrhoeal Disease Research, Bangladesh. Completed at 1 site in Bangladesh. Open to participants aged 6 Months to 24 Months. Per ClinicalTrials.gov, last updated 2009-02-20.

Sponsored by International Centre for Diarrhoeal Disease Research, Bangladesh · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
338
Allocation
Randomized
Ages
6 Months to 24 Months
Sex
All
01

Study 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.

02

Conditions studied

  • Diarrhoea

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Keywords

  • Zinc treatment
  • supplementation
  • Enterotoxigenic E. coli
  • diarrhoea
03

In context

Diarrhea

865 studies on the registry are indexed under Diarrhea; 77 are open to participants now.

This study's planned enrollment of 338 is above the median of 138 across 721 interventional studies indexed under Diarrhea.

Browse Diarrhea studies →

Lead sponsor

International Centre for Diarrhoeal Disease Research, Bangladesh is the lead sponsor of 204 studies on the registry; 30 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 24 Months
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
338 participants (estimated)

Interventions

06

What researchers measure

Primary outcomes

  1. To evaluate innate and adaptive immune response.

  2. Future occurrence of acute diarrhoea, ARI and impetigo.

07

Study locations

1 site
  • ICDDR,B. Mirpur Field Site
    Dhaka, 1212, Bangladesh
08

References and documents

Publications

  • Sheikh A, Shamsuzzaman S, Ahmad SM, Nasrin D, Nahar S, Alam MM, Al Tarique A, Begum YA, Qadri SS, Chowdhury MI, Saha A, Larson CP, Qadri F. Zinc influences innate immune responses in children with enterotoxigenic Escherichia coli-induced diarrhea. J Nutr. 2010 May;140(5):1049-56. doi: 10.3945/jn.109.111492. Epub 2010 Mar 17. PubMed 20237063 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2004, a primary completion of Aug 2006 and a completion of Nov 2006. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 5, 2006
First posted
Dec 6, 2006
Start
Nov 2004
Primary completionActual
Aug 2006
CompletionActual
Nov 2006
Last update
Feb 20, 2009
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 20, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00408356
Collaborators
Bill and Melinda Gates Foundation
First posted
Dec 6, 2006
Start date
Nov 2004
Primary completion
Aug 2006
Completion
Nov 2006
Last update
Feb 20, 2009

Study contacts

Amit Saha, MBBS
study director · International Centre for Diarrhoeal Disease Research, Bangladesh

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2009. You cannot join it, but the record below documents what was studied.

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Discussion

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