| CTRI Number |
CTRI/2020/04/024874 [Registered on: 27/04/2020] Trial Registered Prospectively |
| Last Modified On: |
25/04/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Nutritional assessment in hemodialysis patients |
|
Scientific Title of Study
|
Body composition monitoring and nutritional assessment in hemodialysis patients: A prospective observational study at a tertiary care hospital. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ASHWIN S P |
| Designation |
REGISTRAR, DEPARTMENT OF NPHROLOGY, KMC MANIPAL |
| Affiliation |
KASTURBA MEDICAL COLLEGE, MANIPAL |
| Address |
REGISTRAR, DEPARTMENT OF NEPHROLOGY
KASTURBA MEDICAL COLLEGE, MANIPAL
KARNATAKA
576104
Udupi
KARNATAKA
576104
India |
| Phone |
7259606569 |
| Fax |
|
| Email |
sp.ashwin87@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ASHWIN S P |
| Designation |
REGISTRAR, DEPARTMENT OF NPHROLOGY, KMC MANIPAL |
| Affiliation |
KASTURBA MEDICAL COLLEGE, MANIPAL |
| Address |
REGISTRAR, DEPARTMENT OF NEPHROLOGY
KASTURBA MEDICAL COLLEGE, MANIPAL
KARNATAKA
576104
Udupi
KARNATAKA
576104
India |
| Phone |
7259606569 |
| Fax |
|
| Email |
sp.ashwin87@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
A RAVINDRA PRABHU |
| Designation |
PROFESSOR AND UNIT HEAD, DEPARTMENT OF NPHROLOGY, KMC MANIPAL |
| Affiliation |
KASTURBA MEDICAL COLLEGE, MANIPAL |
| Address |
PROFESSOR AND UNIT HEAD, DEPARTMENT OF NEPHROLOGY
KASTURBA MEDICAL COLLEGE, MANIPAL
KARNATAKA
576104
Udupi
KARNATAKA
576104
India |
| Phone |
9448107771 |
| Fax |
|
| Email |
aravindraprabhu@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Manipal university |
| Address |
REGISTRAR, DEPARTMENT OF NEPHROLOGY, KMC MANIPAL
KARNATAKA-576104 |
| Type of Sponsor |
Research institution |
|
|
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 |
| ASHWIN S P |
KASTURBA HOSPITAL |
DEPARTMENT OF NEPHROLOGY
Udupi
KARNATAKA |
7259606569
sp.ashwin87@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KSTURBA MEDICAL COLLEGE AND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N186||End stage renal disease, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All patients on Haemodialysis for at least 3 months. |
|
| ExclusionCriteria |
| Details |
The patients with acute kidney injury.
History of a pacemaker, defibrillator, metallic sutures, or stent implantation and amputation of a major limb.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To detect under/over nutrition in patients. |
To detect under/over nutrition in patients over 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To detect under/over nutrition
in patients undergoing hemodialysis. |
1 year 6 months |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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
|
N/A |
|
Date of First Enrollment (India)
|
28/04/2020 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
: All patients undergoing hemodialysis for at least 3 months for
chronic kidney disease ailment- Body Mass Index (BMI), anthropometric
measurements, body composition monitoring and basic laboratory evaluation like hemoglobin,
albumin, CRP (C Reactive Protein), Blood urea, Serum creatinine, Serum calcium,
serum phosphorus and PTH (Parathyroid Hormone) will be measured and follow up study
will be done after 6 months |