| CTRI Number |
CTRI/2024/03/063452 [Registered on: 01/03/2024] Trial Registered Prospectively |
| Last Modified On: |
27/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Dietary Patterns And Lifestyle Modifications of Hemodialysis Patients |
|
Scientific Title of Study
|
Dietary Patterns and Lifestyle Modifications of End Stage Renal Disease Patients undergoing Hemo Dialysis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bushra Irfan Kamani |
| Designation |
Student |
| Affiliation |
Dr BMN College of home Science |
| Address |
Room number 902, Msc Clinical Nutrition & Dietetics (part 2) , Post Graduate department, Dr. BMN College of Home Science
338,Rafi Ahmed Kidwai Road, Matunga East, Mumbai , Maharashtra 400019
India
Mumbai
MAHARASHTRA
400019
India |
| Phone |
9819737557 |
| Fax |
|
| Email |
kamanibushra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mrs Rekha P Bhattalwar |
| Designation |
Associate Professor |
| Affiliation |
Dr BMN College of Home Science |
| Address |
Examination cell room, Department of post graduate studies,Sir Vithaldas Thackersey College of Home Science (Autonomous) SNDT Womens University, Juhu, Santacruz (W) , Mumbai 400049
Mumbai
MAHARASHTRA
400049
India |
| Phone |
9820286174 |
| Fax |
|
| Email |
drrekhab12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mrs Rekha P Bhattalwar |
| Designation |
Associate Professor |
| Affiliation |
Dr BMN College of Home Science |
| Address |
Examination cell room, Department of post graduate studies , Sir Vithaldas Thackersey College of Home Science (Autonomous) SNDT Womens University, Juhu, Santacruz (W) , Mumbai 400049
MAHARASHTRA
400049
India |
| Phone |
9820286174 |
| Fax |
|
| Email |
drrekhab12@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr BMN College of Home Science Matunga Department of Postgraduate Studies in Clinical Nutrition and Dietetics |
|
|
Primary Sponsor
|
| Name |
Bushra Irfan Kamani |
| Address |
Dr BMN College of Home Science Matunga East |
| Type of Sponsor |
Other [self sponsored] |
|
|
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 Mrs Rekha P Bhattalwar |
Dr BMN College of Home Science |
Department of post graduate studies in Clinical Nutrition and Dietetics, Dr BMN College Of Home Science , RA Kidwai Road Matunga east mumbai 400019
Mumbai
MAHARASHTRA |
9820286174
drrekhab12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Seva Mandal Education Societys Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NA |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
End Stage Renal Disease Patients visiting hospital for health checkups
Voluntarily agrees to participate
Patients who suffer with comorbidities like Diabetes mellitus, Hypertension etc. |
|
| ExclusionCriteria |
| Details |
Patients who are critically ill
Patients who are admitted in the hospital |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
provide valuable insights into the dietary patterns followed by ESRD patients and their impact on nutritional status.
evidence-based dietary interventions to improve the health outcomes and quality of life of ESRD patients. |
4 weeks |
|
|
Secondary Outcome
|
|
|
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)
|
10/03/2024 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Aim: To Study the dietary pattern and lifestyle modifications of End Stage Renal Disease patients undergoing Hemo-Dialysis. Objectives: · To identify the most common dietary pattern among patients undergoing hemo-dialysis. · To observe the relationship between dietary patterns and nutritional status in hemo-dialysis patients. · To study the impact of dietary interventions on nutritional status and health outcomes in End Stage Renal Disease patients. · To observe the dietary misconceptions in patients undergoing Hemo Dialysis. |