Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000413022
Ethics application status
Approved
Date submitted
19/05/2010
Date registered
24/05/2010
Date last updated
24/05/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
To evaluate the impact of additional delivery strategies (involving the non-medical private sector) for low osmolarity Oral Rehydration Salts (ORS) and zinc supplements for the treatment of acute diarrhoea in under five children on Oral Rehydration Salts (ORS) solution use rate as well as zinc use rate when compared to standard delivery through health facilities.
Scientific title
An Operational Study on the management of acute diarrhoea in Tanzania - Evaluation of new delivery strategies for Oral Rehydration Salts (ORS) and Zinc on use rate in children under five.
Secondary ID [1] 251807 0
NCH08002

Department of Child and Adolescent Health and Development
Secondary ID [2] 251808 0
C6-TSA-009

World Health Organization
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
diarrhoea 257403 0
Condition category
Condition code
Public Health 257552 257552 0 0
Health service research
Infection 257553 257553 0 0
Other infectious diseases
Oral and Gastrointestinal 257576 257576 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Low osmolarity ORS and zinc supplements to treat acute diarrhoea will be provided through health care facilities public and private. Additionally, in the intervention study areas, access to low osmolarity ORS and zinc supplements will be provided to children suffering from acute diarrhoea through the sale of Diarrhoea Treatment Kits (DTK) at a modest price using Part II Pharmacy outlets or village retail shops. These alternative delivery strategies will be used in the study areas for 1 year.
Intervention code [1] 256509 0
Other interventions
Comparator / control treatment
low osmolarity ORS and zinc supplements to treat acute diarrhoea will be provided through health care facilities public and private.
Control group
Active

Outcomes
Primary outcome [1] 258461 0
ORS use rate

Through household surveys using the Maternal, Newborn and Child Health Survey tool described in the protocole
Timepoint [1] 258461 0
1 year after initiation of the intervention
Primary outcome [2] 258462 0
zinc use rate

Through household surveys, using the Maternal, Newborn and Child Health Survey tool described in the protocole
Timepoint [2] 258462 0
1 year after initiation of the intervention
Secondary outcome [1] 264255 0
Proportion of caretakers having bought Diarrhoea Treatment Kits (DTK) from village grocery stores

Through household surveys as described above.
Timepoint [1] 264255 0
1 year after initiation of the intervention

Eligibility
Key inclusion criteria
All under five children living in the intervention and control areas (Tanzania) presenting with diarrhoea
Minimum age
1 Months
Maximum age
5 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization by using a randomization table from a statistics book.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50000
Accrual to date
Final
Recruitment outside Australia
Country [1] 2644 0
Tanzania, United Republic Of
State/province [1] 2644 0

Funding & Sponsors
Funding source category [1] 256996 0
Other
Name [1] 256996 0
World Health Organization
Country [1] 256996 0
Switzerland
Primary sponsor type
University
Name
Muhimbili University on Health and Allied Sciences (MUHAS)
Address
PO Box 65001
Dar es Salaam
Country
Tanzania, United Republic Of
Secondary sponsor category [1] 256259 0
Government body
Name [1] 256259 0
Ministry of Health and Social Welfare
Address [1] 256259 0
Dr. N. Rusibamayila
National Integrated Management of Childhood Illnesses (IMCI) Coordinator
Ministry of Health and Social Welfare (MoHSW)
P. O. Box 9083
Dar es Salaam
Country [1] 256259 0
Tanzania, United Republic Of

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259009 0
MUHAS Ethical Review Board
Ethics committee address [1] 259009 0
MUHAS
PO Box 65001
Dar es Salaam
Ethics committee country [1] 259009 0
Tanzania, United Republic Of
Date submitted for ethics approval [1] 259009 0
Approval date [1] 259009 0
18/12/2009
Ethics approval number [1] 259009 0
Ethics committee name [2] 259010 0
World Health Organization Ethical Review Board
Ethics committee address [2] 259010 0
World Health Organization
20 Avenue Appia
1211 Geneva 27
Ethics committee country [2] 259010 0
Switzerland
Date submitted for ethics approval [2] 259010 0
Approval date [2] 259010 0
15/11/2009
Ethics approval number [2] 259010 0

Summary
Brief summary
The proposed study is a community cluster-randomized operational study to evaluate the use of low osmolarity ORS and zinc as a treatment modality during acute diarrhoea in children aged one month to 5 years. During the course of the operational study in both the intervention study area and in the control study area low osmolarity ORS and zinc supplements to treat acute diarrhoea will be provided through health care facilities public and private. However, in the intervention study areas additional access to low osmolarity ORS and zinc supplements and will be provided to children suffering from acute diarrhoea through the sale of Diarrhoea Treatment Kits (DTK) at a modest price using Part II Pharmacy outlets or village retail shops.
A baseline, midterm and end-of-intervention household and health facility surveys will be undertaken to determine the characteristics related to the treatment of an episode of acute diarrhoea in a child less than five years of age. The study will be undertaken in Bagamoyo and Kisarawe Districts for Tanzania Mainland.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31183 0
Address 31183 0
Country 31183 0
Phone 31183 0
Fax 31183 0
Email 31183 0
Contact person for public queries
Name 14430 0
Olivier Fontaine
Address 14430 0
WHO/CHild and Adolescent Health and Development (CAH)
20 Avenue Appia
1211 Geneva 27
Country 14430 0
Switzerland
Phone 14430 0
+41 22 791 28 94
Fax 14430 0
Email 14430 0
[email protected]
Contact person for scientific queries
Name 5358 0
Maulidi Fataki
Address 5358 0
MUHAS
PO BOX 65001
Dar es Salaam
Country 5358 0
Tanzania, United Republic Of
Phone 5358 0
+255 22 215 03 02
Fax 5358 0
Email 5358 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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