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

Diarrhea Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00942812
• Other study ID #: 1235-Ped/ERC-09
• Status: Completed
• Phase: Phase 4
• First received: July 20, 2009
• Last updated: August 9, 2011
• Start date: July 2009
• Est. completion date: September 2010

Study information

• Verified date: July 2009
• Source: Aga Khan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: ERC Aga Khan University, Pakistan:
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7200
• Est. completion date: September 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Months to 59 Months

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diarrhea

Intervention

Other:
• Diarrhea Pack
Low osmolality ORS, Zinc tablets, water purification tablets and pictorial chart
• ORS
ORS has been supplied to diarrheal cases as standard care through the LHW program at community level

Locations

Country	Name	City	State
Pakistan	AKU Project Office	Khairpur	Sind

Sponsors (2)

Lead Sponsor	Collaborator
Aga Khan University	John Snow, Inc.

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in Diarrhea related morbidity		1 year	No