An effectiveness trial examining the addition of zinc to the current case management package of diarrhoea in a primary health care setting (India)
| ISRCTN | ISRCTN96456353 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN96456353 |
| ClinicalTrials.gov (NCT) | NCT00278681 |
| Protocol serial number | HNI 04008 |
| 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 Nations Children's Fund (UNICEF) - India, Department of Biotechnology - Ministry of Sciences and Biotechnology (India) |
- Submission date
- 12/09/2005
- Registration date
- 01/02/2006
- Last edited
- 28/01/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
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 | Effectiveness of zinc supplementation plus oral rehydration salts compared with oral rehydration salts alone as a treatment for acute diarrhea in a primary care setting: a cluster randomized trial |
| Study objectives | Zinc supplementation together with Oral Rehydration Therapy (ORT) will: 1. Increase Oral Rehydration Sachet (ORS) use rates 2. Reduce antimicrobial use rates 3. Increase care seeking use rates during diarrhoea |
| Ethics approval(s) | Ethcis approval received from the World Health Organization (WHO) on the 4th April 2005. |
| Health condition(s) or problem(s) studied | Diarrhoea |
| Intervention | Implementation of the zinc intervention (zinc and ORT versus ORT alone) at community and primary health care level (phase III) - one year. Formative research (phase I) and pilot intervention (phase II) have already been completed - one year. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Zinc |
| Primary outcome measure(s) |
1. Oral Rehydration Sachet (ORS) use rates per cluster |
| Key secondary outcome measure(s) |
1. Diarrhoea prevalence |
| Completion date | 31/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | All |
| Target sample size at registration | 6000 |
| Key inclusion criteria | All children with diarrhoea living in the study area. |
| Key exclusion criteria | As this study is an effectiveness study, looking at the impact of the intervention implemented in normal conditions, there is no exclusion criteria. |
| Date of first enrolment | 01/08/2005 |
| Date of final enrolment | 31/12/2006 |
Locations
Countries of recruitment
- India
- 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2008 | 28/01/2019 | Yes | No |
Editorial Notes
28/01/2019: Publication reference added
