Community Based Intervention and Evaluation of the Impact of Social Marketing of a Diarrhea Management Pack

This study has been completed.

Sponsor:

Collaborator:

John Snow, Inc.

Information provided by:

Aga Khan University

ClinicalTrials.gov Identifier:

NCT00942812

First received: July 20, 2009

Last updated: August 9, 2011

Last verified: July 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	July 20, 2009
Last Updated Date	August 9, 2011
Start Date ^ICMJE	July 2009
Primary Completion Date	June 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 20, 2009)	Reduction in Diarrhea related morbidity [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00942812 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Community Based Intervention and Evaluation of the Impact of Social Marketing of a Diarrhea Management Pack
Official Title ^ICMJE	A Community Based Intervention and Evaluation of the Impact of Social Marketing of a Diarrhea Management Pack(Comprising of Low Osmolality ORS, Zinc Tablets, Water Purification Tablets and Pictorial Chart) on Childhood Diarrhea.
Brief Summary	Diarrhoeal diseases are still the major paediatric health concern worldwide, contributing for 2.5 million annual deaths in children. Although the treatment of diarrhoeal illness as per the World Health Organization (WHO) guidelines brings about a considerable decline in the burden of the disease but there is still a lot to be done for this issue. Zinc supplementation along with Oral Rehydration Solution (ORS) has emerged as a potent approach to treat diarrhoea. It is believed that the children having zinc deficiency are at high risk of developing infectious diseases which eventually lead to a high burden of mortality. In order to prevent and effectively manage diarrheal episodes, it is important that water purification tablets, zinc and oral rehydration salt is always available in each household. Though, these products are easily available in the market separately, but are rarely available together in any household. If these products are made available in a single packet, it is likely to be an effective strategy in combating diarrheal diseases in the community.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Diarrhea
Intervention ^ICMJE	Other: Diarrhea Pack Low osmolality ORS, Zinc tablets, water purification tablets and pictorial chart Other: ORS ORS has been supplied to diarrheal cases as standard care through the LHW program at community level
Study Arm (s)	Experimental: Intervention A diarrhea Pack comprising of low osmolality ORS, Zinc, water purification sachets and pictorial chart. Intervention: Other: Diarrhea Pack Control Standard Care through National LHW (Lady Health Workers)program Intervention: Other: ORS
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	7200
Completion Date	September 2010
Primary Completion Date	June 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Children under 5 years of age suffering from diarrhea residing in study area and having consent to participate Exclusion Criteria: Failure to provide consent or children having debilitating illness or requiring emergency hospital care.
Gender	Both
Ages	2 Months to 59 Months
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Pakistan

Administrative Information
NCT Number ^ICMJE	NCT00942812
Other Study ID Numbers ^ICMJE	1235-Ped/ERC-09
Has Data Monitoring Committee	Yes
Responsible Party	Dr. Zulfiqar A Bhutta, Aga Khan University
Study Sponsor ^ICMJE	Aga Khan University
Collaborators ^ICMJE	John Snow, Inc.
Investigators ^ICMJE	Not Provided
Information Provided By	Aga Khan University
Verification Date	July 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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