Zinc supplementation during acute childhood diarrhoea: a cluster randomised trial in rural Pakistan

ISRCTN ISRCTN73387335
DOI https://doi.org/10.1186/ISRCTN73387335
Secondary identifying numbers WHO/HNI04006
Submission date
08/02/2005
Registration date
10/02/2005
Last edited
17/10/2007
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
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 22 791 2894
Email fontaineo@who.int

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesThe 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(s)Ethics approval received from the World Health Organization (WHO) Ethical Review Committee on the 26th January 2006.
Health condition(s) or problem(s) studiedChildhood diarrhoea
InterventionAdministration 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 typeSupplement
Primary outcome measure1. 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 measuresNo secondary outcome measures
Overall study start date26/01/2005
Completion date26/01/2007

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit2 Months
Upper age limit59 Months
SexBoth
Target number of participants5000 children (2500 per group)
Key inclusion criteria1. 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
Key exclusion criteria1. Chronic and recurrent diarrhoea
2. Children less then 2 months or above 5 years
Date of first enrolment26/01/2005
Date of final enrolment26/01/2007

Locations

Countries of recruitment

  • Pakistan
  • Switzerland

Study participating centre

World Health Organization
Geneva-27
CH 1211
Switzerland

Sponsor information

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

No information available

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