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
|
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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 |

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 |
- Age
- Sex
- Weight
- Body Mass index
- Duration of diarrhoea before admission
- Stool volume
- Dehydration status
- 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
- Weight gain
- Length gain
- Episodes of illness during follow-up

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Ages Eligible for Study: | 12 Months to 59 Months (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00321126
Principal Investigator: | Swapan Kumar Roy, MBBS, M.Sc, Ph. D | International Centre for Diarrhoeal Disease Research, Bangladesh |
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 |