| CTRI Number |
CTRI/2017/04/008442 [Registered on: 28/04/2017] Trial Registered Prospectively |
| Last Modified On: |
28/04/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Intervention with Customized Menu Plan] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Evaluate The Dietary Intake of Subjects With Chronic Kidney Disease by Supplementing a Customized Menu Plan and Development of Mobile Application for Patients With Chronic Kidney Disease |
|
Scientific Title of Study
|
Influence of Dietary Intake of Renal Specific Nutrients on the Serum Parameters of Subjects with Chronic Kidney Disease and Development of Standardized Evidence Based Dietary Plan Mobile Application - A Randomized Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Abhinaya S S Rao |
| Designation |
Ph.D. Research Scholar |
| Affiliation |
Sri Ramachandra University |
| Address |
Department Of Clinical Nutrition, Sri Ramachandra University,
No:1, Ramachandra Nagar, Porur, Chennai - 600 116
Department Of Clinical Nutrition, Sri Ramachandra University,
No:1, Ramachandra Nagar, Porur, Chennai - 600 116
Kancheepuram
TAMIL NADU
600116
India |
| Phone |
9884984602 |
| Fax |
|
| Email |
abhinayassrao@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Abhinaya S S Rao |
| Designation |
Ph.D. Research Scholar |
| Affiliation |
Sri Ramachandra University |
| Address |
Department Of Clinical Nutrition, Sri Ramachandra University,
No:1, Ramachandra Nagar, Porur, Chennai - 600 116
Department Of Clinical Nutrition, Sri Ramachandra University
No:1, Ramachandra Nagar, Porur, Chennai - 600 116
Kancheepuram
TAMIL NADU
600116
India |
| Phone |
9884984602 |
| Fax |
|
| Email |
abhinayassrao@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Abhinaya S S Rao |
| Designation |
Ph.D. Research Scholar |
| Affiliation |
Sri Ramachandra University |
| Address |
Department Of Clinical Nutrition, Sri Ramachandra University
No:1, Ramachandra Nagar, Porur, Chennai - 600 116
Department Of Clinical Nutrition, Sri Ramachandra University
No:1, Ramachandra Nagar, Porur, Chennai - 600 116
Kancheepuram
TAMIL NADU
600116
India |
| Phone |
9884984602 |
| Fax |
|
| Email |
abhinayassrao@gmail.com |
|
|
Source of Monetary or Material Support
|
| Founder - Chancellor, Shri N.P.V Ramasamy Udayar Research Fellowship,
Sri Ramachandra University
No:1, Ramachandra Nagar, Porur, Chennai - 600 116 |
|
|
Primary Sponsor
|
| Name |
Sri Ramachandra University |
| Address |
No:15 North Tank Square Street, Triplicane, Chennai - 600 005 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 P Soundararajan |
Sri Ramachandra University |
Department Of Clinical Nutrition,
Sri Ramachandra University
No:1, Ramachandra nagar, Porur, Chennai- 600 116
Kancheepuram
TAMIL NADU |
9884984602
abhinayassrao@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Sri Ramachandra University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Subjects with CKD stage III and IV and GFR – 20 – 45 ml/min, Co morbid conditions – Hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dietary Intervention |
The Interventional group would be provided with a customized menu plan for a period of seven days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Subjects diagnosed with Chronic Kidney Disease stage III and IV.
2)Subjects with GFR – 20 – 45 ml/min
3)Subjects with co morbid conditions – Hypertension
4)Subjects able to give consent and who are able to come for all visits.
5)Subjects not taking calcium binder, Vitamin D or phosphate binders or supplements
|
|
| ExclusionCriteria |
| Details |
1)Age group – 1 to 19 years (Pediatric subjects)
2)Subjects diagnosed of Chronic kidney disease – Stage I, II
3)Subjects on dialysis
4)Subjects who had undergone renal transplant
5)Subjects with Diabetes Mellitus
6)Subjects with severe co morbid conditions such as malignancies, hepatic cholestasis, hepatitis B and C
7. Subjects under steroid and warfarin treatment |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Correlate renal specific nutrient intake with renal biochemical parameters like BUN, Creatinine, Sodium, Potassium and Phosphorus |
One week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To develop a database and create a mobile app on renal nutrition |
Six to Eight Months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
01/05/2017 |
| 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) |
Not Yet Recruiting |
|
Publication Details
|
Yet to be published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Need for the study
Nutrition
therapy forms a very important component in management of renal disease.
Subjects with Renal Disease are posed with a lot of dietary restrictions which
leads to psychological stress. In spite of these restrictions the progression
of kidney disease ultimately leading to End Stage Renal Disease are high. Dietary
counseling for CKD patients is complex and patients are frequently confused by
the multitude of recommendations. There are no human clinical trials that have
clearly demonstrated that lowering dietary phosphate absorption in patients
with normal phosphorus levels. Grain based vegetarian diets reported to have
decreased phosphorus absorption compared with meat or casein based diets.(Sharon et al. 2011). These authors
have highlighted the need for larger studies demonstrating the feasibility of a
structured dietary exposure approach to give appropriate recommendations.
Aim/Broad Objective
ü The study aims at developing an
individualized dietary plan and evaluate its influence on the renal parameters
of subjects with chronic disease and based on the outcome, develop an evidence
based dietary plan mobile application for use by the subjects with chronic
kidney disease. |