| CTRI Number |
CTRI/2013/02/003399 [Registered on: 15/02/2013] Trial Registered Retrospectively |
| Last Modified On: |
15/02/2013 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Oral Rehydration Solution] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effects of two oral rehydration solutions,Low Osmolarity ORS and ReSoMal(Reduced Osmolarity Solution For Malnourished) in children with Severe Acute Malnutrition with diarrhea |
|
Scientific Title of Study
|
A randomized controlled trial to compare the safety and efficacy of low osmolarity ORS versus modified Rehydration Solution for Malnourished children (RESOMAL) for treatment of children with severe acute malnutrition and diarrhea |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ruchika Kumar |
| Designation |
Postgraduate |
| Affiliation |
Lady Hardinge Medical College & Associated Hospitals |
| Address |
Department of Pediatrics
Lady Hardinge Medical College and Associated Hospitals
Bangla Sahib Road
New Delhi
Central
DELHI
110001
India |
| Phone |
09711353475 |
| Fax |
|
| Email |
ruchika2908@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Praveen Kumar |
| Designation |
Professor |
| Affiliation |
Lady Hardinge MedicalCollege |
| Address |
Department of Pediatrics
Lady Hardinge Medical College and Associated Hospitals
Bangla Sahib Road
New Delhi
Central
DELHI
110008
India |
| Phone |
09868579672 |
| Fax |
|
| Email |
pkpaed@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Praveen Kumar |
| Designation |
Professor |
| Affiliation |
Lady Hardinge MedicalCollege |
| Address |
Department of Pediatrics
Lady Hardinge Medical College and Associated Hospitals
Bangla Sahib Road
New Delhi
Azamgarh
DELHI
110008
India |
| Phone |
09868579672 |
| Fax |
|
| Email |
pkpaed@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pediatrics
Lady Hardinge Medical College and Associated Hospitals
New Delhi 110008 |
|
|
Primary Sponsor
|
| Name |
Department of Pediatrics |
| Address |
Lady Hardinge Medical College and Assoc Hospitals
Bhagat Singh Road
New Delhi-110 001 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| RuchikaKumar |
Department of Pediatrics |
Lady Hardinge Medical College and Associated Hospitals
Bangla Sahib Road
New Delhi
Central
DELHI |
09711353475
ruchika2908@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee lady hardinge medical college and associate hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Children With Severe Acute Malnutrition and Diarrhea, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Low Osmolarity ORS |
Low Osmolarity ORS to be used as oral rehydration solution in children with Severe Acute Malnutrition with diarrhea as per WHO guidelines on oral rehydration, every half hourly for 2 hours followed by alternate hourly with diet for 10 hours till correction of hydration status. |
| Comparator Agent |
RESOMAL (Modified Rehydration Solution for Malnourished children) |
RESOMAL to be used as oral rehydration solution in children with Severe Acute Malnutrition with diarrhea as per WHO guidelines on oral rehydration, every half hourly for 2 hours followed by alternate hourly with diet for 10 hours till correction of hydration status. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
59.00 Month(s) |
| Gender |
Both |
| Details |
Children having acute diarrhea(of <14 days) with Severe Acute Malnutrition
Severe Acute Malnutrition defined as weight for height < -3 SD per WHO growth charts and or bilateral pedal edema |
|
| ExclusionCriteria |
| Details |
Child received I/V fluid before admission
Child with shock
Child with convulsion or any other life threatening complication
Child with known renal or heart disease
History of not passed urine for more than 6 hours
Electrolyte disturbance requring I/V correction |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Number of children who develop hyponatremia. (serum sodium less than 135 mmol/litre) |
48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of hypokalemia |
48 hours |
| Stool frequency |
48 hours |
| Episodes of vomiting |
48 hours |
| Incidence of fluid overload |
48hrs |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/07/2012 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A randomized
controlled trial to compare the safety and efficacy of low osmolarity ORS
versus modified Rehydration Solution for
Malnourished children (RESOMAL) for treatment of children with severe acute
malnutrition and diarrhea conducted in Kalawati saran children hospital, New Delhi , India. the primary outcome measure will be incidence of hyponatremia at 0,12,24,48 hrs.Secondary outcome measures will be incidence
of hypokalemia, stool frequency and stool output in both the groups during 48 hours, episodes of vomiting in both the groups, incidence of fluid overload.
|