Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
Society for Applied Studies Ministry of Science and Technology, India United Nations Children's Fund, Delhi World Health Organization |
---|---|
Information provided by: | Society for Applied Studies |
ClinicalTrials.gov Identifier: | NCT00278746 |
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.
Condition | Intervention |
---|---|
Diarrhea Mortality Hospitalization |
Drug: Zinc and ORS Drug: ORS only |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment |
Official Title: | An Effectiveness Trial Examining the Addition of Zinc to the Current Case Management Package of Diarrhea in a Primary Health Care Setting. |
Enrollment: | 20032 |
Study Start Date: | January 2005 |
Study Completion Date: | September 2006 |
Primary Completion Date: | September 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Zinc and ORS
|
Drug: Zinc and ORS
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
|
2: No Intervention
ORS only
|
Drug: ORS only
In the control sites ORS alone was promoted
|
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.
Ages Eligible for Study: | 1 Month to 5 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
India, Delhi | |
Society for Applied Studies | |
New Delhi, Delhi, India, 110017 |
Principal Investigator: | Nita Bhandari, PhD | Society for Applied Studies |
Responsible Party: | Society for Applied Studies, New Delhi ( Nita Bhandari ) |
Study ID Numbers: | PR-5268/PID/20/198/2004 |
Study First Received: | January 13, 2006 |
Last Updated: | July 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00278746 History of Changes |
Health Authority: | India: Ministry of Health |
zinc diarrhea cluster randomization hospitalization |
Signs and Symptoms Diarrhea Signs and Symptoms, Digestive |
Zinc Trace Elements Micronutrients |
Signs and Symptoms Diarrhea Signs and Symptoms, Digestive Growth Substances Physiological Effects of Drugs |
Zinc Trace Elements Micronutrients Pharmacologic Actions |