Condition category
Signs and Symptoms
Date applied
01/02/2006
Date assigned
01/02/2006
Last edited
24/10/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.who.int/

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)

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

Publication citations

Additional files

Editorial Notes