| 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
|
|
|
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
|
|
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. |