Condition category
Signs and Symptoms
Date applied
12/09/2005
Date assigned
01/02/2006
Last edited
17/10/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Olivier Fontaine

ORCID ID

Contact details

World Health Organization
20
Avenue Appia
Geneva-27
CH-1211
Switzerland
+41 (0)22 791 28 94
fontaineo@who.int

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00278681

Protocol/serial number

HNI 04008

Study information

Scientific title

Acronym

Study hypothesis

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

Ethcis approval received from the World Health Organization (WHO) on the 4th April 2005.

Study design

Evaluation-based, randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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 names

Zinc

Primary outcome measures

1. Oral Rehydration Sachet (ORS) use rates per cluster
2. Antimicrobial use rates per cluster

Secondary outcome measures

1. Diarrhoea prevalence
2. Duration and severity of diarrhoeal episodes
3. Hospitalisation rates (overall, for diarrhoea, for Acute Respiratory Infections [ARI])

Overall trial start date

01/08/2005

Overall trial end date

31/12/2006

Reason abandoned

Eligibility

Participant inclusion criteria

All children with diarrhoea living in the study area.

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

6000

Participant 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.

Recruitment start date

01/08/2005

Recruitment end date

31/12/2006

Locations

Countries of recruitment

India

Trial participating centre

World Health Organization
Geneva-27
CH-1211
Switzerland

Sponsor information

Organisation

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

Sponsor details

20
Avenue Appia
Geneva-27
CH-1211
Switzerland
+41 (0)22 791 28 94
fontaineo@who.int

Sponsor type

Research organisation

Website

http://www.who.int

Funders

Funder type

Research organisation

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

United Nations Children's Fund (UNICEF) - India

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Department of Biotechnology - Ministry of Sciences and Biotechnology (India)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes