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 (0)22 791 28 94
fontaineo@who.int
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HNI 4001
Study information
Scientific title
Acronym
Study hypothesis
Zinc supplementation of diarrhoeic children, together with Oral Rehydration Therapy (ORT), will:
1. Increase ORT/Oral Rehydration Sachet (ORS) use rates
2. Decrease antimicrobial use rates
Ethics approval
Ethics approval received on 15/04/2005.
Study design
Evaluation-based, randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Diarrhoea
Intervention
Health Facility and Community Zinc and ORT versus ORT alone intervention (phase III). A one year, formative research (phase I) and one year pilot intervention have already been completed.
Intervention type
Other
Phase
Phase III
Drug names
Primary outcome measures
1. ORS use rates per cluster
2. Antimicrobial use rates per cluster
3. Prevalence/incidence of diarrhoea per cluster
Secondary outcome measures
1. Percentage of children with diarrhoea treated with zinc
2. Percentage of children with diarrhoea treated with ORS/ORT
3. Percentage of children with diarrhoea treated with inappropriate antibiotics
Overall trial start date
01/08/2005
Overall trial end date
31/07/2006
Reason abandoned
Eligibility
Participant inclusion criteria
All under five children with diarrhoea living in the study area.
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
6000
Participant exclusion criteria
This is an implementation study looking at the effectiveness of a new intervention conducted as naturally as possible through the normal public health system and through already in place community health workers. This is not an efficacy study, therefore, there is no exclusion criteria as all children presenting with diarrhoea should receive the new intervention.
Recruitment start date
01/08/2005
Recruitment end date
31/07/2006
Locations
Countries of recruitment
Mali
Trial participating centre
World Health Organization
Geneva-27
CH-1211
Switzerland
Sponsor information
Organisation
The Department of Child and Adolescent Health and Development (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 and Development (CAH)/World Health Organization (WHO) (Switzerland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
United States Agency for International Development (USAID) (USA)
Alternative name(s)
U.S. Agency for International Development, USAID
Funding Body Type
government organisation
Funding Body Subtype
federal/national government
Location
United States of America
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