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

Study Overview
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Brief Summary
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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
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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.

Official Title
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An Effectiveness Trial Examining the Addition of Zinc to the Current Case Management Package of Diarrhea in a Primary Health Care Setting.

Conditions
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Diarrhea, Mortality, Hospitalization

Intervention / Treatment
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* Drug: Zinc and ORS
* Drug: ORS only


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children aged 1 month to 5 years with diarrhea Exclusion Criteria: Illness requiring referral to hospital

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Zinc and ORS were promoted for treatment of diarrhea in underfive children | Drug: Zinc and ORS<br>* 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<br>|
| Other: 2<br>Promoted routine management of diarrhea in underfive with ORS | Drug: ORS only<br>* Promoted routine management of diarrhea in underfive with ORS<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 20 months (Jan 2005 to Sep 2006) | 
| - Reduction in visits to health care providers for treatment of illness |  | 20 months (Jan 2005 to Sep 2006) | 
| - Reduction in drug use; antibiotics and other drugs during diarrheal illnesses |  | 20 months (Jan 2005 to Sep 2006) | 
| - Increase in ORS use during diarrhea in the intervention communities. |  | 20 months (Jan 2005 to Sep 2006) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - Reduction in all cause hospitalizations |  | 20 months (Jan 2005 to Sep 2006) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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zinc, diarrhea, cluster randomization, hospitalization