Zinc supplementation during acute childhood diarrhoea: a cluster randomised trial in rural Pakistan
ISRCTN | ISRCTN73387335 |
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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
Scientific
World Health Organization
20, Avenue Appia
Geneva-27
CH 1211
Switzerland
Phone | +41 22 791 2894 |
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fontaineo@who.int |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
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 | 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 study start date | 26/01/2005 |
Completion date | 26/01/2007 |
Eligibility
Participant type(s) | Patient |
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Age group | Child |
Lower age limit | 2 Months |
Upper age limit | 59 Months |
Sex | Both |
Target number of participants | 5000 children (2500 per group) |
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
CH 1211
Switzerland
Sponsor information
The Department of Child and Adolescent Health (CAH)/World Health Organization (WHO) (Switzerland)
Research organisation
Research organisation
20, Avenue Appia
Geneva-27
CH 1211
Switzerland
Website | http://www.who.int |
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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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |