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

Primary Purpose

Diarrhea, Mortality, Hospitalization

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Zinc and ORS
ORS only
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, cluster randomization, hospitalization

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 referral to hospital

Sites / Locations

  • Society for Applied Studies

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

1

2

Arm Description

Zinc and ORS were promoted for treatment of diarrhea in underfive children

Promoted routine management of diarrhea in underfive with ORS

Outcomes

Primary Outcome Measures

To evaluate in a community based controlled effectiveness trial whether addition of zinc as a therapeutic modality for diarrhea delivered through existing channels, including at village level to the current case management package for under-five children
- Reduction in visits to health care providers for treatment of illness
- Reduction in drug use; antibiotics and other drugs during diarrheal illnesses
- Increase in ORS use during diarrhea in the intervention communities.

Secondary Outcome Measures

- Reduction in all cause hospitalizations

Full Information

First Posted
January 13, 2006
Last Updated
June 15, 2015
Sponsor
Society for Applied Studies
Collaborators
Ministry of Science and Technology, India, United Nations Children's Fund, Delhi, World Health Organization
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1. Study Identification

Unique Protocol Identification Number
NCT00278746
Brief Title
Addition of 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 Diarrhea in a Primary Health Care Setting.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
September 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Society for Applied Studies
Collaborators
Ministry of Science and Technology, India, United Nations Children's Fund, Delhi, World Health Organization

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Several studies have shown the beneficial effect of zinc treatment in acute diarrhea. There was a significant reduction in duration of the treated episodes and in their severity as measured by diarrheal stool output or frequency. Zinc is a potentially important immunomodulator or nutraceutical which may have great impact as therapeutic agent in conditions like diarrhea and pneumonia. The issue is whether and how zinc should be introduced in primary health care programs for treatment of acute diarrhea. A practical, sustainable intervention for introduction of zinc as treatment of acute diarrhoea in national programs is therefore required. This study aimed to address this issue.
Detailed Description
This cluster randomized trial aimed at evaluating in a community based controlled effectiveness trial whether addition of 2RDA zinc as a therapeutic modality to the current case management package for diarrhoea in children aged between 1 month and 5 years, delivered through existing channels at village level, resulted in reduction in care seeking from health care providers, antibiotic and other drug use and increase in ORS use rates. The intervention was being implemented in 6 PHCs; 3 intervention and 3 control. Based on the experience of a pilot study and the formative research findings, common sources visited by caregivers for care seeking during morbidity were identified. These sources were selected as channels in partnership with the local government, to distribute zinc strips and ORS packets in intervention sites and only ORS packets in control sites. These channels were physicians (at the PHC and private practitioners), the auxiliary nurse midwives (ANMs) and Anganwadi workers (AWWs) of the Integrated Child Development Services (ICDS) Scheme. All the channels were trained and supplies of zinc strips and ORS packets, and ORS packets only were distributed in each pair of PHC in intervention and control sites respectively. Recommendations were developed and translated into local vernacular. A poster, incorporating these recommendations and pictures of zinc strips and ORS packets, was designed and put up at various places in the intervention sites. For outcome measurements, cross sectional surveys were conducted at 6 monthly intervals. Process evaluation activities, which included observations of different channels and exit interviews with mothers after they had visited a channel were conducted. In the two groups, zinc was used in 36.5% and 59.8% diarrheal episodes and ORS in 34.8% and 59.2% episodes in the 4 weeks preceding interviews in intervention areas. In control areas, ORS was used in 7.8% and 9.8% episodes. Care seeking for diarrhea, prescription of drugs of unknown identity and antibiotics for diarrhea reduced in intervention communities. The study demonstrated that an intervention to improve diarrhea management with ORS and zinc is feasible and highly acceptable in rural Indian communities. The resulting health benefits were substantial and accomplished with a reduction in the cost to families for diarrhea treatment from current practices.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20032 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Zinc and ORS were promoted for treatment of diarrhea in underfive children
Arm Title
2
Arm Type
Other
Arm Description
Promoted routine management of diarrhea in underfive with ORS
Intervention Type
Drug
Intervention Name(s)
Zinc and ORS
Intervention Description
Government and private providers and village health workers were trained to prescribe zinc and ORS for use in diarrheal episodes in 1 month to 5 years old children in intervention communities
Intervention Type
Drug
Intervention Name(s)
ORS only
Intervention Description
Promoted routine management of diarrhea in underfive with ORS
Primary Outcome Measure Information:
Title
To evaluate in a community based controlled effectiveness trial whether addition of zinc as a therapeutic modality for diarrhea delivered through existing channels, including at village level to the current case management package for under-five children
Time Frame
20 months (Jan 2005 to Sep 2006)
Title
- Reduction in visits to health care providers for treatment of illness
Time Frame
20 months (Jan 2005 to Sep 2006)
Title
- Reduction in drug use; antibiotics and other drugs during diarrheal illnesses
Time Frame
20 months (Jan 2005 to Sep 2006)
Title
- Increase in ORS use during diarrhea in the intervention communities.
Time Frame
20 months (Jan 2005 to Sep 2006)
Secondary Outcome Measure Information:
Title
- Reduction in all cause hospitalizations
Time Frame
20 months (Jan 2005 to Sep 2006)

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 referral to hospital
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
18450870
Citation
Bhandari N, Mazumder S, Taneja S, Dube B, Agarwal RC, Mahalanabis D, Fontaine O, Black RE, Bhan MK. Effectiveness of zinc supplementation plus oral rehydration salts compared with oral rehydration salts alone as a treatment for acute diarrhea in a primary care setting: a cluster randomized trial. Pediatrics. 2008 May;121(5):e1279-85. doi: 10.1542/peds.2007-1939.
Results Reference
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Addition of Zinc to the Current Case Management Package of Diarrhea in a Primary Health Care Setting

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