Zinc Supplementation in Shigella Patients

NCT00321126 | Completed Phase 3

• 1 other identifier: 97-020
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Testing Effect of Intervention

Keywords

Zinc; Shigella; Children; Bangladesh

Outcome Measures

Primary Outcomes (7)

• Age

• Sex

• Weight

• Body Mass index

• Duration of diarrhoea before admission

• Stool volume

• Dehydration status

Secondary Outcomes (8)

• In blood: total and differential WBC counts,C-reactive protein, albumin, serum electrolytes and creatinine concentration

• Quantitation of luminal neutriphils

• Immune response

• Duration of recovery

• Presence of blood and mucous in stool

Interventions

Children in the zinc group received 20 mg of elemental zinc as acetate per day in a twice-daily dose for two weeks. DRUG

Eligibility Criteria

• Age: 12 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Measles infection in the past six months
• Presence of obvious systemic illnesses
• Severe malnutrition
• Residence in a location requiring a journey of\>2 hour from the Dhaka Hospital of the ICDDR,B
• Refusal to give consent

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead
• Karolinska Institutet: collaborator

Related Publications (1)

• Roy SK, Raqib R, Khatun W, Azim T, Chowdhury R, Fuchs GJ, Sack DA. Zinc supplementation in the management of shigellosis in malnourished children in Bangladesh. Eur J Clin Nutr. 2008 Jul;62(7):849-55. doi: 10.1038/sj.ejcn.1602795. Epub 2007 Jun 6.

  PMID: 17554249 DERIVED

MeSH Terms

Conditions

Dysentery, Bacillary

Condition Hierarchy (Ancestors)

Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Dysentery; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Swapan Kumar Roy, MBBS, M.Sc, Ph. D

  International Centre for Diarrhoeal Disease Research, Bangladesh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 2, 2006
• First Posted: May 3, 2006
• Study Start: January 1, 1999
• Study Completion: April 1, 2002
• Last Updated: May 3, 2006

Record last verified: 2006-05