| CTRI Number |
CTRI/2014/02/004399 [Registered on: 12/02/2014] Trial Registered Retrospectively |
| Last Modified On: |
11/02/2014 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Benefits of glutamine enriched feed over normal routine feed in traumatic brain injury patients:A double blinded RCT |
|
Scientific Title of Study
|
A randomized double blind controlled trial to assess the benefits of glutamine enriched feed over normal routine feed in traumatic brain injury patients. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
REENA VT |
| Designation |
MSC NURSING STUDENT |
| Affiliation |
AIIMS |
| Address |
COLLEGE OF NURSING
AIIMS
NEWDELHI
New Delhi
DELHI
110029
India |
| Phone |
8510088637 |
| Fax |
|
| Email |
vtreena27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
L Gopichandran |
| Designation |
Lecturer |
| Affiliation |
AIIMS |
| Address |
COLLEGE OF NURSING
AIIMS
NEWDELHI
New Delhi
DELHI
110029
India |
| Phone |
08130930287 |
| Fax |
|
| Email |
pravigopi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
REENA VT |
| Designation |
MSC NURSING STUDENT |
| Affiliation |
AIIMS |
| Address |
COLLEGE OF NURSING
AIIMS
NEWDELHI
DELHI
110029
India |
| Phone |
8510088637 |
| Fax |
|
| Email |
vtreena27@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS |
| Address |
AIIMS
NEWDELHI |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Sumit Sinha |
TC3 ICU & TC5 WARD,JPNATC,AIIMS |
AIIMS
NEWDELHI
New Delhi
DELHI |
9868398244
sumitneuro@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Head Injured, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
glutamine enriched feed |
glutamine 20 gm/day for 10days |
| Comparator Agent |
normal routine feed |
normal routine feed that is being given for head injured patients in the selected hospital setting. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Traumatic brain injured patients with GCS 5-12
Body mass index falling between 17-40
Age(18-60)
Subjects who give consent to practice
|
|
| ExclusionCriteria |
| Details |
Multiple organ system dysfunction
Immune suppressive conditions(HIV,TB)
Associated trauma such as pulmonary contusion, extremity fracture ,chest or intra-abdominal injuries
Cancer or Taking chemotherapy or radiotherapy in last 6 months
Chronic Obstructive Pulmonary Disease
Renal failure
Hepatic dysfunction
Previous organ transplantation
Pregnancy
Indication of Total Parentral Nutrition
Previously on antibiotics
Chronic alcoholics and smokers |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| nutritional status |
on day 3,5 and 10 after initiation of glutamine enriched feed |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| infectious complications |
on day 3,5 and 10 after initiation of glutamine enriched feed |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/08/2013 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
- Head
injury patients who met the inclusion criteria were randomly assigned on
interventional group and control group by the third party.Subjects
in both interventional and control group were started on enteral feed within 24-48
hours after the time of admission as ordered by the physician and the
patients in the interventional group were supplemented with 20g of
glutamine per day for 10 days along with the normal routine feed.The
patients were assigned to two groups by the third party but the
investigator was not known about the feeding regimen of each group other
than the group name as A or BThe
addition of glutamine was only known by the dietician or the corresponding
people from the dietetics department and the third party who was doing the randomization.Patients in
both groups were assessed for nutritional status (hemoglobin, serum
protein, serum albumin, serum urea, mid arm circumference, triceps skin
fold thickness and mid arm muscle circumference) on 0day, 5th
day and 10th day.Patients in
both group were assessed for
infectious complications (Total Leucocyte Count, Fever and Culture studies
specific to any signs of infection as identified by the treating doctor if
there is fever>100F or TLC>10000/mm3) on 0 day, 3rd day,
5th day and 10th day. The number
of ventilator days, no of days of ICU stay and no of days of
hospitalization were calculated from patient records at discharge.
|