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

July 1, 2008 updated by: Society for Applied Studies

An Effectiveness Trial Examining the Addition of Zinc to the Current Case Management Package of Diarrhoea in a Primary Health Care Setting. Phase I

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.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

The pilot study was conducted in a primary health centre (population ~33000) in Faridabad district of the state of Haryana in India. Formative research identified perceptions of caregivers regarding childhood diarrhea, causation and management, care seeking sources and caregivers expectations from healthcare providers. Caregivers in households with children under 5 years old were interviewed in a cross sectional survey to ascertain family characteristics, ORS prescription and use rates, drug prescription rates by healthcare providers and other variables of interest.

In partnership with the local government, channels for distribution of zinc and ORS packets were defined. The channels included physicians (at PHC and private practitioners), auxiliary nurse midwives (ANMs) and Anganwadi workers (AWWs)of the Integrated Child Development Services (ICDS) scheme. Recommendations were developed and translated into local vernacular. A poster, which incorporated the recommendations and pictures of zinc strip and ORS packets, was designed. These posters were put up at different places in the study area. All channels were trained and provided with the supplies of zinc strips and ORS packets except the private practitioners who received only zinc strips and advised caregivers to take ORS packets from government channels. Effectiveness of this pilot program was assessed through 2 cross sectional surveys, 3 and 6 months post training.

The cross sectional surveys revealed that the prescription of syrups, tablets, powders and injections during diarrhea and cost of treatment decreased significantly. Prescription and use of ORS increased markedly. Zinc tablets were prescribed and used in about half the episodes 6 months after start of intervention. It was feasible to train various government and community channels to promote zinc as treatment of acute diarrhea through the primary health care system.

Study Type

Interventional

Enrollment (Actual)

2364

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Delhi
      • New Delhi, Delhi, India, 110017
        • Society for Applied Studies

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 5 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children aged 1 month to 5 years with diarrhea

Exclusion Criteria:

  • Illness requiring hospitalization (referral)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: I
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
- Reduction in antibiotics and other drugs use during diarrheal illnesses
Time Frame: August 2003 to August 2004
August 2003 to August 2004
- Increase in ORS use during diarrhea
Time Frame: August 2003 to August 2004
August 2003 to August 2004
- Reduction in hospitalizations; all cause and diarrhea related
Time Frame: August 2003 to August 2004
August 2003 to August 2004

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2003

Primary Completion (ACTUAL)

August 1, 2004

Study Completion (ACTUAL)

August 1, 2004

Study Registration Dates

First Submitted

January 13, 2006

First Submitted That Met QC Criteria

January 13, 2006

First Posted (ESTIMATE)

January 18, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

July 2, 2008

Last Update Submitted That Met QC Criteria

July 1, 2008

Last Verified

July 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HRN-A-96-90006-00
  • 77955

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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