| CTRI Number |
CTRI/2015/06/005924 [Registered on: 17/06/2015] Trial Registered Retrospectively |
| Last Modified On: |
15/06/2015 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Nutritional Assessment and Health Status of Dialysis patients |
|
Scientific Title of Study
|
Nutritional Assessment and Health Status of Patients undergoing Dialyis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bahar Mukri |
| Designation |
STUDENT |
| Affiliation |
DR. B.M.N COLLEGE OF HOME SCIENCE |
| Address |
Ahmedji Manzil, Shaikh Misri Dargah Road, Antophill, Mumbai 400037.
Ahmedji Manzil, Shaikh Misri Dargah Road, Antophill, Mumbai 400037.
Mumbai
MAHARASHTRA
400037
India |
| Phone |
9769153304 |
| Fax |
|
| Email |
baharmukri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mrs Rekha Battalwar |
| Designation |
Associate professor, Food Science and Nutrition department |
| Affiliation |
Associate professor, Food Science and Nutrition Department |
| Address |
S.V.T. College of home Science (Autonomous), S.N.D.T. Women;s University, Juhu, Tara Road, Mumbai 400 049
S.V.T. College of home Science (Autonomous), S.N.D.T. Women;s University, Juhu, Tara Road, Mumbai 400 049
Mumbai
MAHARASHTRA
400049
India |
| Phone |
9769153304 |
| Fax |
|
| Email |
drrekhab12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bahar Mukri |
| Designation |
STUDENT |
| Affiliation |
DR. B.M.N COLLEGE OF HOME SCIENCE |
| Address |
Ahmedji Manzil, Shaikh Misri Dargah Road, Antophill, Mumbai 400037.
Ahmedji Manzil, Shaikh Misri Dargah Road, Antophill, Mumbai 400037.
Mumbai
MAHARASHTRA
400037
India |
| Phone |
9769153304 |
| Fax |
|
| Email |
baharmukri@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Bahar Z Mukri |
| Address |
Ahmedji Manzil, Shaikh Misri Dargah Road, Antophill, Mumbai 400037 |
| Type of Sponsor |
Other [] |
|
|
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 Sudhir salvi |
Lalbaugcha raja dialysis centre |
Lalbaugcha Raja Dialysis centre, Chiwada galli, Lalbaug Industrial Estate, Near Kamal Darshan, Besides Narayan Udyog Bhavan, Lalbaug, Mumbai- 12
Mumbai
MAHARASHTRA |
022-247-15583
lalbaugrajacenter@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Seva Mandal Education Society |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
dialysis, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing dialysis. |
|
| ExclusionCriteria |
| Details |
Patients undergoing temporary dialysis. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Nutritional assessment and health status of patients undergoing dialysis |
10th February 2015 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the nutritonal and health status of patients of private and government hospital undergoing dialysis. |
nil |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
04/04/2014 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Nutritional assessment and health status of patients undergoing dialysis Aim: The aim is to study the nutritional assessment and health status of patients undergoing dialysis. Objectives: To asses the nutritional intake and health status of the subjects. To assess the anthropometric measurements and biochemical status. To study the role of the quality and quantity of carbohydrate, proteins and fat in the management of dialysis patients. To evaluate malnutrition status by Subjective Global Assessment (SGA) method. To compare the nutiriotnal and health status between private and government hospital patients undergoing dialysis. Hypothesis: Health status does not play an important role in patients undergoing dialysis. |