Condition category
Infections and Infestations
Date applied
22/08/2007
Date assigned
23/08/2007
Last edited
05/02/2015
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 Phalguni Dutta

ORCID ID

Contact details

National Institute of Cholera and Enteric Diseases
Scheme XM
Beliaghata
P-33 CIT Road
Kolkata
700010
India
-
niced@cal2.vsnl.net.in

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

036150

Study information

Scientific title

A randomised controlled trial of resistant starch as adjuvant to reduced osmolarity oral rehydration solution in the treatment of children with diarrhoea

Acronym

Study hypothesis

The hypothesis is that addition of amylase resistant starch as an adjunct to reduced osmolarity Oral Rehydration Solution (ORS) will significantly decrease stool fluid losses and shorten duration of diarrhoeal illness in children with non-cholera diarrhoea.

Ethics approval

Not provided at time of registration

Study design

Single-centre randomised controlled single-blinded clinical trial with two arms

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Acute infective diarrhoea in children

Intervention

After informed consent from parents, eligible children will be randomised to receive standard treatment for diarrhoea including reduced osmolarity World Health Organisation (WHO) oral rehydration solution or reduced osmolarity WHO ORS solution containing High Amylose Maize Starch (HAMS) 50 grams per litre. Randomisation will be done in blocks of 40 and achieved by packing the appropriate ORS packets (suitable for reconstitution in 200 ml water) in sealed opaque covers bearing the study number. The randomisation and packaging will be done in Vellore and the study will be done in Kolkata.

Children will be rehydrated within the first 4 to 6 hours following standard guidelines, and administered their normal food including breast milk where applicable, after rehydration is completed. Supplements of zinc sulphate 20 mg per day will be given for 14 days. Clinical parameters of hydration will be monitored, urine output will be measured, and stool collected in diapers and weighed. Intravenous fluids can be administered during the trial at the discretion of the supervising paediatrician depending on clinical the indication and will be recorded as unscheduled IV fluid administration. Stool consistency will be graded and the study stopped when the stool is 'pasty' or 'formed'.

Intervention type

Drug

Phase

Not Applicable

Drug names

Osmolarity Oral Rehydration Solution (ORS)

Primary outcome measures

1. Stool output in first 48 hours
2. Duration of diarrhoea - time from onset of ORS administration to first formed stool

Secondary outcome measures

Need for unscheduled administration of IV fluids

Overall trial start date

01/03/2007

Overall trial end date

31/01/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male children aged 6 months to 3 years
2. Diarrhoea (defined as greater than three watery stools/24 hours, with "some" dehydration) for three days or less
3. Children with severe dehydration may be included if stable after Intravenous (IV) rehydration

Participant type

Patient

Age group

Child

Gender

Male

Target number of participants

210

Participant exclusion criteria

1. Bloody diarrhoea
2. Concurrent severe illness - pneumonia, meningitis or other severe infections
3. Grade II and IV malnutrition

Recruitment start date

01/03/2007

Recruitment end date

31/12/2007

Locations

Countries of recruitment

India

Trial participating centre

National Institute of Cholera and Enteric Diseases
Kolkata
700010
India

Sponsor information

Organisation

Christian Medical College (India)

Sponsor details

Department of Gastrointestinal Sciences
Williams Research Building
Ida Scudder Road
Vellore
632004
India
+91 (0)416 228 2052
rama@cmcvellore.ac.in

Sponsor type

Hospital/treatment centre

Website

http://www.cmch-vellore.edu

Funders

Funder type

Charity

Funder name

Wellcome Trust

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

international

Location

United Kingdom

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