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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00942812
First Posted: July 21, 2009
Last Update Posted: August 10, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
John Snow, Inc.
Information provided by:
Aga Khan University
  Purpose

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 Intervention Phase
Diarrhea Other: Diarrhea Pack Other: ORS Phase 4

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Aga Khan University:

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

Enrollment: 7200
Study Start Date: July 2009
Study Completion Date: September 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Control
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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.
  Contacts and Locations
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


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

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 Submitted: July 20, 2009
First Posted: July 21, 2009
Last Update Posted: August 10, 2011
Last Verified: July 2009

Keywords provided by Aga Khan University:
Children
Recovery
Diarrhea Pack
Social Marketing

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