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CTRI Number  CTRI/2018/01/011067 [Registered on: 01/01/2018] Trial Registered Prospectively
Last Modified On: 09/12/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [nutrition counselling]  
Study Design  Single Arm Study 
Public Title of Study   dietary intervention in chronic kidney disease 
Scientific Title of Study   Effect of dietary and lifestyle intervention on quality of life in End Stage Renal Disease patients: a randomised control trial 
Trial Acronym  Dietary and life style intervention 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Puja Dudeja 
Designation  Associate Professor 
Affiliation  Armed forces Medical College 
Address  department o community medicine afmc
ARMED FORCES MEDICAL COLLEGE, PUNE
Pune
MAHARASHTRA
411040
India 
Phone  9673382611  
Fax    
Email  puja_dudeja@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Puja Dudeja 
Designation  Associate Professor 
Affiliation  Armed forces Medical College 
Address  department o community medicine afmc
ARMED FORCES MEDICAL COLLEGE, PUNE

MAHARASHTRA
411040
India 
Phone  9673382611  
Fax    
Email  puja_dudeja@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Puja Dudeja 
Designation  Associate Professor 
Affiliation  Armed forces Medical College 
Address  department o community medicine afmc
ARMED FORCES MEDICAL COLLEGE, PUNE

MAHARASHTRA
411040
India 
Phone  9673382611  
Fax    
Email  puja_dudeja@yahoo.com  
 
Source of Monetary or Material Support  
O/o Director General Armed forces Medical Services M block Ministry of Defence, New Delhi 
 
Primary Sponsor  
Name  Director General Armed Forces Medical Services  
Address  L block Ministry of Defence New Delhi  
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Puja Dudeja  Command Hospital Pune  Room no 2 (renal OPD)
Pune
MAHARASHTRA 
9673382611
9673382611
puja_dudeja@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Armed Forces Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N186||End stage renal disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  follow up of those CKD patients without nutrition counselling  follow up of those CKD patients without nutrition counselling 
Intervention  Nutrition counselling  one to one counselling distribution of booklet on diet in renal disease 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  chronic kidney disease patients attending OPD of a tertiary care hospital  
 
ExclusionCriteria 
Details  patients of chronic kidney disease admitted in hospital 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Quality of life score  4, 8, 12,16 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
improvement in blood urea and serum creatinine levels  4, 8, 12,16 weeks 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   N/A 
Date of First Enrollment (India)   02/04/2018 
Date of Study Completion (India) 03/06/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
Yıldız AU, Kurcer MA. Life Style Education and Counseling Improved Quality of Life and Renal Function in Patients with Chronic Kidney Disease.TAFPrev Med Bull. 2012;11(6):667-72 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  

    Background

Patients on dialysis require adequate nutrition in order to prevent Protein Energy Malnutrition (PEM). Failure to diagnose malnutrition leads to neglect of nutritional support during illness. Active nutritional support has been shown to improve outcomes and reduce cost of treatment in severely malnourished patients. Nutritional status is frequently ignored in many dialysis centres while simple methods of nutritional assessment could have a favourable impact on patient management.

Various studies have shown that renal protection treatment strategy in Patients with renal disease include dietary management for protein and salt,weight control and life style modification. Institution of lifestyle measures (diet and exercise) along with medical treatment can prove cost effective in the long run by preventing progression to End Stage Renal Disease.

In the current project, all the dialysis patients will be included in the study. At Command Hospital Pune around 60 patients are registered at any point of time for dialysis. The patients are given dietary advice by the nephrologists. However, there are no written guidelines regarding diet and exercises available in the OPD. There is no standard module being used for this. No hand outs are being given to patients regarding diet and lifestyle modification. Hence, the present study has been proposed to study the effect of dietary and lifestyle intervention on quality of life  of patients.

 

 

 
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