ISRCTN ISRCTN34307051
DOI https://doi.org/10.1186/ISRCTN34307051
Secondary identifying numbers HNI 4001
Submission date
01/02/2006
Registration date
01/02/2006
Last edited
14/07/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Olivier Fontaine
Scientific

World Health Organization
20, Avenue Appia
Geneva-27
CH-1211
Switzerland

Phone +41 (0)22 791 28 94
Email fontaineo@who.int

Study information

Study designEvaluation-based, randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title-
Study objectivesZinc 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(s)Ethics approval received on 15/04/2005.
Health condition(s) or problem(s) studiedDiarrhoea
InterventionHealth 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 typeOther
Primary outcome measure1. ORS use rates per cluster
2. Antimicrobial use rates per cluster
3. Prevalence/incidence of diarrhoea per cluster
Secondary outcome measures1. 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 study start date01/08/2005
Completion date31/07/2006

Eligibility

Participant type(s)Patient
Age groupChild
Upper age limit5 Years
SexBoth
Target number of participants6000
Key inclusion criteriaAll under five children with diarrhoea living in the study area.
Key exclusion criteriaThis 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.
Date of first enrolment01/08/2005
Date of final enrolment31/07/2006

Locations

Countries of recruitment

  • Mali
  • Switzerland

Study participating centre

World Health Organization
Geneva-27
CH-1211
Switzerland

Sponsor information

The Department of Child and Adolescent Health and Development (CAH)/World Health Organization (WHO) (Switzerland)
Research organisation

20, Avenue Appia
Geneva-27
CH-1211
Switzerland

Website http://www.who.int/
ROR logo "ROR" https://ror.org/01f80g185

Funders

Funder type

Research organisation

The Department of Child and Adolescent Health and Development (CAH)/World Health Organization (WHO) (Switzerland)

No information available

United States Agency for International Development (USAID) (USA)
Government organisation / National government
Alternative name(s)
U.S. Agency for International Development, Agency for International Development, USAID
Location
United States of America

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan