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Zinc Supplementation in Shigella Patients

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ClinicalTrials.gov Identifier: NCT00321126
Recruitment Status : Completed
First Posted : May 3, 2006
Last Update Posted : May 3, 2006
Sponsor:
Collaborator:
Karolinska Institutet
Information provided by:
International Centre for Diarrhoeal Disease Research, Bangladesh

Study Description
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Brief Summary:
Shigellosis is a major cause of morbidity and mortality in young children in Bangladesh and other developing countries. Further, the increasing emergence of resistance to a wide range of antibiotics is of great concern. Another major public health problem in Bangladesh is malnutrition, which is closely linked with shigellosis and with a high mortality. In Shigellosis, a heavy nutritional burden is placed on children and vital micronutrients such as vitamin A is lost in the urine. We recently found that the immune response in S. Flexneri infection was lower in children who were severely malnourished (weight-for-age≤65% as a percentage of the National Centre for Health Statistics median) when compared to children with weight-for-age from >65-75%. T cell responses were primarily affected with lowered CD4/CD8 ratios, lowered proliferative responses to T cell mitogens, Conconavalin A (ConA) and phytohaemagglutinin (PHA). However, proliferation of pheripheral blood mononuclear cells (PBMs) was lowered only in the presence of autologous plasma suggesting that a factor(s) in plasma, probably nutritional, rather than a defect in cells themselves was responsible. In children with S. dysenteriae 1 infection, proliferative responses to PHA were similarly lowered in the presence of autologous plasma but inhibition correlated to lowered transferring levels in plasma and not to the weight-for-age of the children. Also severely malnourished children with either S. flexneri or S. dysenteriae 1 infection were more severely ill. These findingings show that immunity in malnourishrd children with shigella infection is impaired which may lead to more severe illness. As zinc has profound effects on immunity as well as clinical outcome in diarrhoeal diseases, it is possible that zinc deficiency may be a factor in reducing immunity and increasing severity of acute illness in malnourished children with shigellosis. In this study, we will investigate the effect of zinc supplementation, in a double blind placebo controlled trial, on inflammatory responses, outcome of acute illness and growth following recovery from acute illness with S. flexneri infection.

Condition or disease Intervention/treatment Phase
Testing Effect of Intervention Drug: Children in the zinc group received 20 mg of elemental zinc as acetate per day in a twice-daily dose for two weeks. Phase 3

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Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Effect of Zinc Supplementation on the Immune and Inflammatory Responses of Children to Shigella Flexneri Infection, and Correlation With Clinical Severity of Illness and Growth Following recoveryEffect of Zinc Supplementation on the Immune and Inflammatory Responses of Children to Shigella Flexneri Infection, and Correlation With Clinical Severity of Illness and Growth Following Recovery
Study Start Date : January 1999
Study Completion Date : April 2002

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Age
  2. Sex
  3. Weight
  4. Body Mass index
  5. Duration of diarrhoea before admission
  6. Stool volume
  7. Dehydration status

Secondary Outcome Measures :
  1. In blood: total and differential WBC counts,C-reactive protein, albumin, serum electrolytes and creatinine concentration
  2. Quantitation of luminal neutriphils
  3. Immune response
  4. Duration of recovery
  5. Presence of blood and mucous in stool
  6. Weight gain
  7. Length gain
  8. Episodes of illness during follow-up

Eligibility Criteria
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Ages Eligible for Study:   12 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age between 12-59 months
  2. Moderate malnutrition (61-75% Weight / Age – NCHS Median)
  3. Duration of diarrhoea of 5 days
  4. Culture confirmed shigella spp in stool on enrolment

Exclusion Criteria:

  1. Measles infection in the past six months
  2. Presence of obvious systemic illnesses
  3. Severe malnutrition
  4. Residence in a location requiring a journey of>2 hour from the Dhaka Hospital of the ICDDR,B
  5. Refusal to give consent
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00321126


Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
Karolinska Institutet
Investigators
Principal Investigator: Swapan Kumar Roy, MBBS, M.Sc, Ph. D International Centre for Diarrhoeal Disease Research, Bangladesh
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00321126     History of Changes
Other Study ID Numbers: 97-020
First Posted: May 3, 2006    Key Record Dates
Last Update Posted: May 3, 2006
Last Verified: May 2006

Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:
Zinc
Shigella
Children
Bangladesh

Additional relevant MeSH terms:
Dysentery, Bacillary
Enterobacteriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Dysentery
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Intestinal Diseases
Zinc
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs