A randomised controlled trial of resistant starch as adjuvant to reduced osmolarity oral rehydration solution in the treatment of children with diarrhoea
| ISRCTN | ISRCTN53674257 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN53674257 |
| Secondary identifying numbers | 036150 |
- Submission date
- 22/08/2007
- Registration date
- 23/08/2007
- Last edited
- 05/02/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
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 Phalguni Dutta
Scientific
Scientific
National Institute of Cholera and Enteric Diseases
Scheme XM
Beliaghata
P-33 CIT Road
Kolkata
700010
India
| niced@cal2.vsnl.net.in |
Study information
| Study design | Single-centre randomised controlled single-blinded clinical trial with two arms |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | A randomised controlled trial of resistant starch as adjuvant to reduced osmolarity oral rehydration solution in the treatment of children with diarrhoea |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Osmolarity Oral Rehydration Solution (ORS) |
| Primary outcome measure | 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 study start date | 01/03/2007 |
| Completion date | 31/01/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Months |
| Upper age limit | 3 Years |
| Sex | Male |
| Target number of participants | 210 |
| Key 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 |
| Key exclusion criteria | 1. Bloody diarrhoea 2. Concurrent severe illness - pneumonia, meningitis or other severe infections 3. Grade II and IV malnutrition |
| Date of first enrolment | 01/03/2007 |
| Date of final enrolment | 31/12/2007 |
Locations
Countries of recruitment
- India
Study participating centre
National Institute of Cholera and Enteric Diseases
Kolkata
700010
India
700010
India
Sponsor information
Christian Medical College (India)
Hospital/treatment centre
Hospital/treatment centre
Department of Gastrointestinal Sciences
Williams Research Building
Ida Scudder Road
Vellore
632004
India
| Phone | +91 (0)416 228 2052 |
|---|---|
| rama@cmcvellore.ac.in | |
| Website | http://www.cmch-vellore.edu |
"ROR" |
https://ror.org/00c7kvd80 |
Funders
Funder type
Charity
Wellcome Trust
Private sector organisation / International organizations
Private sector organisation / International organizations
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
