| CTRI Number |
CTRI/2022/05/042798 [Registered on: 25/05/2022] Trial Registered Prospectively |
| Last Modified On: |
24/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Chronic kidney disease patients undergoing dialysis treatment are more witness to malnutrition, so essential to check food intake patterns. Handgrip strength, anthropometry, and skinfold thickness are also measured for finding their health state. |
|
Scientific Title of Study
|
Investigation of diet pattern, anthropometry and handgrip strength of chronic kidney disease patient undergoing hemodialysis in 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 |
PGPrithviraj |
| Designation |
Post Graduate Student |
| Affiliation |
Manipal College of Health Profession, Manipal Academy of Higher Education. |
| Address |
Department of Renal Replacement Therapy and Dialysis Technology, Manipal College of Health Profession, Manipal Academy of Higher Education, Manipal,
Udupi,
KARNATAKA
576104
India.
Udupi
KARNATAKA
576104
India |
| Phone |
9159783576 |
| Fax |
|
| Email |
prithviraj.g@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravindra Prabhu A |
| Designation |
Professor |
| Affiliation |
Kasturba medical college |
| Address |
Department of Nephrology, Kasturba medical college, Manipal,
Udupi,
KARNATAKA
576104
India.
Udupi
KARNATAKA
576104
India |
| Phone |
9448107771 |
| Fax |
|
| Email |
ravindra.prabhu@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ravindra Prabhu A |
| Designation |
Professor |
| Affiliation |
Kasturba medical college |
| Address |
Department of Nephrology, Kasturba medical college, Manipal,
Udupi,
KARNATAKA
576104
India.
Udupi
KARNATAKA
576104
India |
| Phone |
9448107771 |
| Fax |
|
| Email |
ravindra.prabhu@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital, Manipal |
|
|
Primary Sponsor
|
| Name |
Kasturba Hospital |
| Address |
Kasturba Hospital and Medical college, Manipal, Udupi. |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| PG PRITHVIRAJ |
Kasturba Medical and College Hospital |
Department of Nephrology, Kasturba hospital, Manipal-576104, Udupi, KARNATAKA
Udupi
KARNATAKA |
9159783576
prithviraj.g@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KASTURBA MEDICAL COLLEGE AND KASTURBA HOSPITAL INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N186||End stage renal disease, |
|
|
Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients on maintenance hemodialysis patients for more than three months with age above 18 years |
|
| ExclusionCriteria |
| Details |
Patients who are in ICU
Patients with AKI
Patients with hand deformities
Patients on peritoneal dialysis treatment |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Dietary pattern of CKD patients undergoing hemodialysis |
One week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Analyzing handgrip strength of hemodialysis patients.
Measuring the anthropometry for nutritional status of hemodialysis patients.
|
one week |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
25/05/2022 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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)?
Response - NO
|
|
Brief Summary
|
Chronic kidney disease (CKD) is known as kidney damage that last longer than three months, as determined by structural or functional abnormalities of the kidney, with or without a reduction in Glomerular Filtration Rate, according to KDIGO. In hemodialysis patients because of kidney failure there will be some restriction in diet and they can intake only some foods for their nutritional support. Their nutritional status will be reduced due to not taking the needed food which shows them week and leads to mortality. So in this study we are going to investigate their diet pattern to identify whether the patients is taking correct diet to find their health status. With this we are using the anthropometry used for body composition in which we measures the skin fold thickness and handgrip strength to measure of the maximum static force that a hand can squeeze using a dynamometer. Using the food frequency questionnaire and by asking to patients we can get to know about their diet what they are consuming then for anthropometry we use vernier caliper for measuring the skin fold thickness and for hand grip strength we use jamar dynamometer machine for measuring the strength of patient. |