Contact information
Type
Scientific
Primary contact
Dr Olivier Fontaine
ORCID ID
Contact details
World Health Organization
20
Avenue Appia
Geneva-27
CH 1211
Switzerland
+41 22 791 2894
fontaineo@who.int
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
WHO/HNI04006
Study information
Scientific title
Acronym
Study hypothesis
The hypothesis being tested is that distribution of zinc through existing government and private health care system will reduce incidence of childhood diarrhoea, and antibiotic use by at least 30%.
The objectives of this trial are:
1. To evaluate if the administration of zinc supplement for 14 days to children with acute diarrhoea will lead to:
1.1. Reduction in use of Oral Rehydration Sachets (ORS) in the community, and
1.2. Reduction in use of antibiotics and anti-diarrhoeal medications at the community level
2. To document the acceptance of the treatment as well as the adherence to the treatment instructions
3. Reduction in the severity of diarrhoea and improved recovery rates
4. Reduction in rates of hospitalisation and need for intravenous rehydration
5. Reduced child mortality due to diarrhoea
Ethics approval
Ethics approval received from the World Health Organization (WHO) Ethical Review Committee on the 26th January 2006.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Childhood diarrhoea
Intervention
Administration of 10 to 20 mg elemental zinc daily through oral rehydration versus the existing program of oral rehydration alone in management of acute diarrhoea for 14 days. No placebo is being used in the control clusters.
Intervention type
Supplement
Phase
Not Specified
Drug names
Zinc supplementation
Primary outcome measures
1. ORS use rate
2. Antibiotic use rate
3. Overall drug use rate for diarrhoea
4. Incidence/prevalence of diarrhoea
5. Duration of diarrhoea/episodes in days
6. Duration of use of ORS, antibiotics and zinc
7. Prevalence /incidence of vomiting
8. Hospitalisation rate for diarrhoea
9. Hospitalisation rate for all causes
10. Total expenditure per household and per episode of diarrhoea
Secondary outcome measures
No secondary outcome measures
Overall trial start date
26/01/2005
Overall trial end date
26/01/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. Children with diarrhoea from 6 to 59 months and 2 to 6 months presenting to any health care facility including both public and private
2. Informed consent
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
5000 children (2500 per group)
Participant exclusion criteria
1. Chronic and recurrent diarrhoea
2. Children less then 2 months or above 5 years
Recruitment start date
26/01/2005
Recruitment end date
26/01/2007
Locations
Countries of recruitment
Pakistan
Trial participating centre
World Health Organization
Geneva-27
CH 1211
Switzerland
Sponsor information
Organisation
The Department of Child and Adolescent Health (CAH)/World Health Organization (WHO) (Switzerland)
Sponsor details
20
Avenue Appia
Geneva-27
CH 1211
Switzerland
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
The Department of Child and Adolescent Health (CAH)/World Health Organization (WHO) (Switzerland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary