Zinc introduction trial in Bougouni District, Mali
| ISRCTN | ISRCTN34307051 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN34307051 |
| Protocol serial number | HNI 4001 |
| Sponsor | The Department of Child and Adolescent Health and Development (CAH)/World Health Organization (WHO) (Switzerland) |
| Funders | The Department of Child and Adolescent Health and Development (CAH)/World Health Organization (WHO) (Switzerland), United States Agency for International Development (USAID) (USA) |
- Submission date
- 01/02/2006
- Registration date
- 01/02/2006
- Last edited
- 14/07/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
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 (0)22 791 28 94 |
|---|---|
| fontaineo@who.int |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Evaluation-based, randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | - |
| Study objectives | 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(s) | Ethics approval received on 15/04/2005. |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
1. ORS use rates per cluster |
| Key secondary outcome measure(s) |
1. Percentage of children with diarrhoea treated with zinc |
| Completion date | 31/07/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Upper age limit | 5 Years |
| Sex | All |
| Target sample size at registration | 6000 |
| Key inclusion criteria | All under five children with diarrhoea living in the study area. |
| Key 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. |
| Date of first enrolment | 01/08/2005 |
| Date of final enrolment | 31/07/2006 |
Locations
Countries of recruitment
- Mali
- Switzerland
Study participating centre
World Health Organization
Geneva-27
CH-1211
Switzerland
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 |
