NCT00942812

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7,200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

July 20, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 21, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

August 10, 2011

Status Verified

July 1, 2009

Enrollment Period

11 months

First QC Date

July 20, 2009

Last Update Submit

August 9, 2011

Conditions

Keywords

ChildrenRecoveryDiarrhea PackSocial Marketing

Outcome Measures

Primary Outcomes (1)

  • Reduction in Diarrhea related morbidity

    1 year

Study Arms (2)

Intervention

EXPERIMENTAL

A diarrhea Pack comprising of low osmolality ORS, Zinc, water purification sachets and pictorial chart.

Other: Diarrhea Pack

Control

OTHER

Standard Care through National LHW (Lady Health Workers)program

Other: ORS

Interventions

Low osmolality ORS, Zinc tablets, water purification tablets and pictorial chart

Intervention
ORSOTHER

ORS has been supplied to diarrheal cases as standard care through the LHW program at community level

Control

Eligibility Criteria

Age2 Months - 59 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children under 5 years of age suffering from diarrhea residing in study area and having consent to participate

You may not qualify if:

  • Failure to provide consent or children having debilitating illness or requiring emergency hospital care.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AKU Project Office

Khairpur, Sindh, Pakistan

Location

MeSH Terms

Conditions

Diarrhea

Interventions

ORALIT

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 20, 2009

First Posted

July 21, 2009

Study Start

July 1, 2009

Primary Completion

June 1, 2010

Study Completion

September 1, 2010

Last Updated

August 10, 2011

Record last verified: 2009-07

Locations