Additive effect of resistant starch on oral rehydration therapy and zinc supplementation for children with acute diarrhoea

ISRCTN	ISRCTN06298820
DOI	https://doi.org/10.1186/ISRCTN06298820
Secondary identifying numbers	063150

Submission date: 14/03/2007
Registration date: 14/03/2007
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 B S Ramakrishna
Scientific

Christian Medical College
Department of Gastrointestinal Sciences
Williams Research Building
Ida Scudder Road
Vellore
632004
India

Phone	+91 (0)416 228 2052
Email	rama@cmcvellore.ac.in

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Additive effect of resistant starch on oral rehydration therapy and zinc supplementation for children with acute diarrhoea
Study objectives	To determine if amylase resistant starch, specifically High-Amylose Maize Starch (HAMS), when added to standard World Health Organisation (WHO) Oral Rehydration Solution (ORS) and zinc supplementation, will be superior to standard ORS and zinc supplementation in reducing diarrhoeal duration or stool output in children with acute diarrhoea. This trial will be conducted at two hospitals in Vellore, India. The hospitals, Christian Medical College Hospital, and Community Health And Development (CHAD) Hospital are both affiliated with Christian Medical College. Patient Gender: Male and Female Trial type: Treatment Trial method: Randomised controlled trial Intervention type: High amylose maize starch added to oral rehydration solution Setting: Tertiary care hospital (CMC Hospital) and community hospital (CHAD)
Ethics approval(s)	Institutional Review Board of CMC, Vellore (India), 27/01/2007, ref: IRB(EC)6/1/2007
Health condition(s) or problem(s) studied	Acute infectious diarrhoea
Intervention	Consecutive children presenting to the paediatric emergency room or outpatient clinics at CMC Hospital and CHAD, and fulfilling inclusion criteria, will be offered entry into the study. The admitting paediatrician together with a study nurse or study doctor will obtain informed consent from a parent or legal guardian upon admission. Those children for whom informed consent is obtained will be randomised to one of two treatment arms: 1. Standard ORS and zinc supplementation (control group) 2. HAMS-ORS and Zinc supplementation (experimental group) Children with severe dehydration will also be treated with three to six hours of intravenous fluids as per WHO treatment plan C. Those children with severe dehydration who are not adequately rehydrated after the initial three to six hours of intravenous fluids, and require further intravenous hydration at this time will be excluded from the study. Study numbers for each arm will be generated using a table of random numbers in blocks of ten patients. For practical reasons, subjects at CMC Hospital and CHAD Hospital will have site-specific randomisation blocks and distinct study numbers. Packets containing one of the two different therapies will be sealed with opaque covers bearing serial study numbers; children will be designated to treatment arms by the packet that they receive. Treatment will be prepared and administered by study nurses. Standard ORS will be formulated according to WHO recommendations (sodium 75 mEq/L, potassium 20 mEq/L, chloride 65 mEq/L, glucose 75 mmol/L, citrate 10 mmol/L, osmolarity 245 mOsm/L) by adding a pre-formulated packet to 200 ml water. HAMS-ORS will have 10 g HAMS added to each 200 ml of standard ORS, yielding 50 g/L of HAMS. 20 mg zinc sulfate syrup (20 mg in 5 ml) will be administered to each child daily until cessation of diarrhoea. Children will be offered ORS (standard ORS or HAMS-ORS) according to the appropriate WHO treatment plan based on their level of dehydration. As is standard of care, oral intake of water will be encouraged, as well as re-feeding after an initial rehydration period. Children will be followed until cessation of diarrhoea. While in the hospital, stool consistency will be monitored serially by the patients family member, almost invariably the childs mother, who will be trained how to fill out a stool recording chart that documents time of each bowel movement and stool consistency, according to a modified Bristol Stool Scale. Upon entry to the study, the child's mother will be asked to indicate on the modified Bristol Stool Scale the 'normal' consistency of their child's stool when the child is healthy. End of diarrhoea is defined as the last unformed stool preceding either a 'normal' consistency stool as just described, or a 12-hour period without any bowel movement. If children are discharged prior to cessation of diarrhoea, family members will continue to administer standard ORS or HAMS-ORS and zinc at home, and they will continue to document the time and consistency of each stool until the end of diarrhoea. They will be given instructions to return the completed stool-recording chart to a study nurse. Those who do not return will be called or visited at home.
Intervention type	Supplement
Primary outcome measure	Diarrhoeal duration, defined as time from the start of ORS consumption to the last unformed stool, or the last stool prior to a 12 hour period without any bowel movement.
Secondary outcome measures	1. Stool frequency 2. Diarrhoeal stool output measured by weight. This will be measured only in male children; due to anatomical considerations only male children can have urine collected separately in a urine pouch so that accurate stool weights collected can be measured in pre-weighed diapers 3. Proportion of children who recover from diarrhoea by 24 hours and 48 hours 4. The need for unscheduled intravenous hydration for recurrent severe dehydration 5. Adverse events
Overall study start date	05/03/2007
Completion date	05/12/2007

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	6 Months
Upper age limit	3 Years
Sex	Both
Target number of participants	116
Key inclusion criteria	1. Age six months to three years with acute diarrhoea, defined as more than three episodes of watery stools in the last 24 hours 2. Clinically detectable dehydration to warrant hospital treatment
Key exclusion criteria	1. Blood and mucus in stool 2. Severe coexisting disease, including pneumonia, meningitis, or severe (grades III and IV) malnutrition 3. Vomiting that precludes administration of oral rehydration solution 4. Children with severe dehydration who are still severely dehydrated after three to six hours of intravenous fluids as per WHO treatment plan C
Date of first enrolment	05/03/2007
Date of final enrolment	01/12/2007

Locations

Countries of recruitment

India

Study participating centre

Christian Medical College

Vellore
632004
India

Sponsor information

Christian Medical College (India)
University/education

Department of Gastrointestinal Sciences
Williams Research Building
Ida Scudder Road
Vellore
632004
India

Phone	+91 (0)416 228 2052
Email	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

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