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

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ClinicalTrials.gov Identifier: NCT00942812
Recruitment Status : Completed
First Posted : July 21, 2009
Last Update Posted : August 10, 2011
John Snow, Inc.
Information provided by:
Aga Khan University

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.

Condition or disease Intervention/treatment Phase
Diarrhea Other: Diarrhea Pack Other: ORS Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7200 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : July 2009
Primary Completion Date : June 2010
Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Intervention
A diarrhea Pack comprising of low osmolality ORS, Zinc, water purification sachets and pictorial chart.
Other: Diarrhea Pack
Low osmolality ORS, Zinc tablets, water purification tablets and pictorial chart
Standard Care through National LHW (Lady Health Workers)program
Other: ORS
ORS has been supplied to diarrheal cases as standard care through the LHW program at community level

Primary Outcome Measures :
  1. Reduction in Diarrhea related morbidity [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00942812

AKU Project Office
Khairpur, Sind, Pakistan
Sponsors and Collaborators
Aga Khan University
John Snow, Inc.

Responsible Party: Dr. Zulfiqar A Bhutta, Aga Khan University
ClinicalTrials.gov Identifier: NCT00942812     History of Changes
Other Study ID Numbers: 1235-Ped/ERC-09
First Posted: July 21, 2009    Key Record Dates
Last Update Posted: August 10, 2011
Last Verified: July 2009

Keywords provided by Aga Khan University:
Diarrhea Pack
Social Marketing

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms