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

ISRCTN	ISRCTN73387335
DOI	https://doi.org/10.1186/ISRCTN73387335
Protocol serial number	WHO/HNI04006
Sponsor	The Department of Child and Adolescent Health (CAH)/World Health Organization (WHO) (Switzerland)
Funder	The Department of Child and Adolescent Health (CAH)/World Health Organization (WHO) (Switzerland)

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Ethics approval received from the World Health Organization (WHO) Ethical Review Committee on the 26th January 2006.
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	26/01/2007

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	2 Months
Upper age limit	59 Months
Sex	All
Target sample size at registration	5000
Key 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
Key exclusion criteria	1. Chronic and recurrent diarrhoea 2. Children less then 2 months or above 5 years
Date of first enrolment	26/01/2005
Date of final enrolment	26/01/2007

Locations

Countries of recruitment

Pakistan
Switzerland

Study participating centre

World Health Organization

Geneva-27
CH 1211
Switzerland

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan