| CTRI Number |
CTRI/2021/07/034790 [Registered on: 12/07/2021] Trial Registered Prospectively |
| Last Modified On: |
10/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Diet and nutrition] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Nutrition in chronic kidney disease and dialysis |
|
Scientific Title of Study
|
Comparative analysis of supervised versus conventional dietary intervention on nutritional status, inflammatory markers, physical function and quality of life in dialysis patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR PREETI CHAUDHARY |
| Designation |
DM NEPHROLOGY FIRST YEAR |
| Affiliation |
ABVIMS AND DR. RML HOSPITAL |
| Address |
DEPARTMENT OF NEPHROLOGY
ABVIMS AND DR. RML HOSPITAL
NEW DELHI
INDIA
New Delhi
DELHI
110001
India |
| Phone |
|
| Fax |
|
| Email |
preetiverma9aug@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR LALIT PURSNANI |
| Designation |
PROFESSOR NEPHROLOGY |
| Affiliation |
ABVIMS AND DR. RML HOSPITAL |
| Address |
DEPARTMENT OF NEPHROLOGY
ABVIMS AND DR. RML HOSPITAL
NEW DELHI
INDIA
New Delhi
DELHI
110001
India |
| Phone |
|
| Fax |
|
| Email |
drlalitkpursnani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR MUTHUKUMAR B |
| Designation |
ASSISTANT PROFESSOR- NEPHROLOGY |
| Affiliation |
ABVIMS AND DR. RML HOSPITAL |
| Address |
DEPARTMENT OF NEPHROLOGY
ABVIMS AND DR. RML HOSPITAL
NEW DELHI
INDIA
New Delhi
DELHI
110001
India |
| Phone |
|
| Fax |
|
| Email |
itzmedrmuthu@gmail.com |
|
|
Source of Monetary or Material Support
|
| DM THESIS,
DEPARTMENT OF NEPHROLOGY,
ABVIMS AND DR. RML HOSPITAL,
NEW DELHI,
INDIA
110001 |
|
|
Primary Sponsor
|
| Name |
DEPARTMENT OF NEPHROLOGY |
| Address |
ABVIMS AND DR. RML HOSPITAL
NEW DELHI
INDIA
110001 |
| Type of Sponsor |
Government medical college |
|
|
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 PREETI CHAUDHARY |
ABVIMS AND DR. RML HOSPITAL |
NEPHROLOGY OPD- III floor R.n. S1- S4;
DIALYSIS ROOM- Nursing Home R.n. 11 ,
DEPARTMENT OF NEPHROLOGY
NEW DELHI
INDIA
110001
New Delhi
DELHI |
8307234547
preetiverma9aug@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ABVIMS AND DR RML HOSPITAL INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N185||Chronic kidney disease, stage 5, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Dietary intervention |
Routine OPD based dietary prescription to the patients |
| Intervention |
Supervised Dietary intervention |
Individualised diet plans would be given to the patients after calculating their nutritional deficits. Dietary re-enforcement would be given on individual basis by weekly telephone and video calls. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Age at dialysis initiation >18y
2. CKD5 patients on dialysis for >3m. |
|
| ExclusionCriteria |
| Details |
1. Patients with tunnelled/ non tunnelled catheters as vascular access in hemodialysis.
2. Patients taking irregular dialysis.
3. Hemodynamically unstable patients at study initiation.
4.Patients not able to perform physical activities included in the study because of associated comorbidity.
5.Patients with Hb <7 g/dl, k/c/o GI disease,CLD,PLHA.
6.Patients on any form of oral/iv formula based nutritional supplement.
7. Patients with CI to bioimpedence studies like implanted cardiac devices, metal implants. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effects of supervised home based dietary intervention versus conventional dietary prescription on nutritional status,inflammatory markers, physical function and quality of life in dialysis patients. |
3 and 6 months from initiation of study. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To study prevalence of malnutrition in dialysis patients.
2. To study practices and patterns of nutrition intake in dialysis patients.
3. To study the barriers in adherence to adequate nutritional therapy advised in dialysis patients. |
3 and 6 months from initiation of study |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
15/07/2021 |
| 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="4"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Malnutrition is widely prevalent among patients on dialysis.However, nutritional status is frequently ignored in these patients, while simple methods of nutritional assessment could have a favourable impact on patient management.There is paucity of data on assessment of nutritional status in indian patients with ESRD .Thereby, we planned this study to compare and analyse the supervised home based dietary intervention and conventional dietary prescription on nutritional status, inflammatory markers, physical activity and quality of life in dialysis patients. |