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Effectiveness of Adding Zinc to the Current Case Management Package of Diarrhea in a Primary Health Care Setting

NCT00278681 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 2364

Last updated 2008-07-02

No results posted yet for this study

Summary

Use of zinc in diarrhea may be an effective intervention to reduce hospitalizations and child mortality as it could reach the most vulnerable children in a community and reduce severity of not only diarrhea but also of associated infections. It might also potentially reduce antibiotic use.

We conducted a pilot study prior to conducting a community based controlled effectiveness trial to assess whether addition of zinc as a therapeutic modality for diarrhea delivered through existing channels, reduces visits to health care providers, antibiotic and other drug use, and increases ORS use during diarrhea.

Conditions

Interventions

DRUG

Zinc and ORS

One strip containing 14 dispersible zinc tablets (20 mg each) along with 2 ORS packets were prescribed to all children aged 1 month to 5 years visiting that channel with diarrhea. Infants aged less than 6 months were advised half a zinc tablet in a teaspoonful of breast milk; older children were advised 1 tablet in breast milk or clean water.

Sponsors & Collaborators

Principal Investigators

  • Nita Bhandari, PhD · Society for Applied Studies

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Month
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-08-31
Primary Completion
2004-08-31
Completion
2004-08-31

Countries

  • India

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00278681 on ClinicalTrials.gov