Condition category
Infections and Infestations
Date applied
14/03/2007
Date assigned
14/03/2007
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 B S Ramakrishna

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

063150

Study information

Scientific title

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

Acronym

Study hypothesis

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

Institutional Review Board of CMC, Vellore (India), 27/01/2007, ref: IRB(EC)6/1/2007

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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 patient’s family member, almost invariably the child’s 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

Phase

Not Specified

Drug names

Amylase resistant starch and zinc supplementation

Primary outcome measures

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 trial start date

05/03/2007

Overall trial end date

05/12/2007

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

116

Participant 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

Recruitment start date

05/03/2007

Recruitment end date

01/12/2007

Locations

Countries of recruitment

India

Trial participating centre

Christian Medical College
Vellore
632004
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

University/education

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