An Effectiveness Trial Examining the Addition of Zinc to the Current Case Management Package of Diarrhea in a Primary Health Care Setting.
Sponsor study identifier
interventional
20,032
1 country
1
Study Start
January 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2006
Actual (reported)Study Completion
September 2006
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2006
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2005
Date type not reportedThis date has not been verified as actual or estimated.
January 13, 2006
Actual (reported)January 18, 2006
Actual (reported)September 2006
Actual (reported)September 2006
Actual (reported)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)
- Reduction in all cause hospitalizations
20 months (Jan 2005 to Sep 2006)
Zinc and ORS were promoted for treatment of diarrhea in underfive children
Promoted routine management of diarrhea in underfive with 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
Promoted routine management of diarrhea in underfive with ORS
Society for Applied Studies
New Delhi, National Capital Territory of Delhi, 110017, India
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.
Nita Bhandari, PhD
Society for Applied Studies
20,032 participants (actual enrollment reported by the registry).
First Submitted
January 13, 2006
First Posted
January 18, 2006
Study Start
January 2005
Date type not reportedThis date has not been verified as actual or estimated.
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Primary Completion
September 2006
Actual (reported)Study Completion
September 2006
Actual (reported)Last Updated
June 16, 2015
Record last verified: 2015-06
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Source: ClinicalTrials.gov.
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