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
Funders
Funder type
Charity
Funder name
Wellcome Trust
Alternative name(s)
Wellcome
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