Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00278681
Status:
COMPLETED
Last Update Posted:
2008-07-02
First Post:
2006-01-13
Brief Title:
Effectiveness of Adding Zinc to the Current Case Management Package of Diarrhea in a Primary Health Care Setting
Sponsor:
Society for Applied Studies
Organization:
Society for Applied Studies
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2008-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 AWWsof 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
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 AWWsof 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 77955 | None | None | None |