Condition category
Infections and Infestations
Date applied
08/02/2005
Date assigned
10/02/2005
Last edited
17/10/2007
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 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

http://www.who.int

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

Publication citations

Additional files

Editorial Notes