search
Back to results

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

Primary Purpose

Diarrhea, Hospitalization

Status
Completed
Phase
Phase 1
Locations
India
Study Type
Interventional
Intervention
Zinc and ORS
Sponsored by
Society for Applied Studies
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diarrhea focused on measuring zinc, diarrhea, hospitalization, programme

Eligibility Criteria

1 Month - 5 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Children aged 1 month to 5 years with diarrhea Exclusion Criteria: Illness requiring hospitalization (referral)

Sites / Locations

  • Society for Applied Studies

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

I

Arm Description

Zinc and ORS

Outcomes

Primary Outcome Measures

- Reduction in antibiotics and other drugs use during diarrheal illnesses
- Increase in ORS use during diarrhea
- Reduction in hospitalizations; all cause and diarrhea related

Secondary Outcome Measures

Full Information

First Posted
January 13, 2006
Last Updated
July 1, 2008
Sponsor
Society for Applied Studies
Collaborators
Johns Hopkins University, World Health Organization
search

1. Study Identification

Unique Protocol Identification Number
NCT00278681
Brief Title
Effectiveness of Adding Zinc to the Current Case Management Package of Diarrhea in a Primary Health Care Setting
Official Title
An Effectiveness Trial Examining the Addition of Zinc to the Current Case Management Package of Diarrhoea in a Primary Health Care Setting. Phase I
Study Type
Interventional

2. Study Status

Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
August 2004 (Actual)
Study Completion Date
August 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Society for Applied Studies
Collaborators
Johns Hopkins University, World Health Organization

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhea, Hospitalization
Keywords
zinc, diarrhea, hospitalization, programme

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2364 (Actual)

8. Arms, Groups, and Interventions

Arm Title
I
Arm Type
Experimental
Arm Description
Zinc and ORS
Intervention Type
Drug
Intervention Name(s)
Zinc and ORS
Intervention Description
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.
Primary Outcome Measure Information:
Title
- Reduction in antibiotics and other drugs use during diarrheal illnesses
Time Frame
August 2003 to August 2004
Title
- Increase in ORS use during diarrhea
Time Frame
August 2003 to August 2004
Title
- Reduction in hospitalizations; all cause and diarrhea related
Time Frame
August 2003 to August 2004

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children aged 1 month to 5 years with diarrhea Exclusion Criteria: Illness requiring hospitalization (referral)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nita Bhandari, PhD
Organizational Affiliation
Society for Applied Studies
Official's Role
Principal Investigator
Facility Information:
Facility Name
Society for Applied Studies
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110017
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
16254536
Citation
Bhandari N, Mazumder S, Taneja S, Dube B, Black RE, Fontaine O, Mahalanabis D, Bhan MK. A pilot test of the addition of zinc to the current case management package of diarrhea in a primary health care setting. J Pediatr Gastroenterol Nutr. 2005 Nov;41(5):685-7. doi: 10.1097/01.mpg.0000182799.69675.92.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs