| CTRI Number |
CTRI/2024/06/068985 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
13/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive Other (Specify) [Diet] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study on the effect of Plant based Low Protein Diet among Chronic Kidney Disease Patients from Selected Hospitals in Pune |
|
Scientific Title of Study
|
Effect of Plant Dominant Low Protein Diet among Chronic Kidney Disease Patients from Selected Hospitals in Pune , India - A Randomized Prospective Controlled Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anindita Ghosh |
| Designation |
PhD Scholar |
| Affiliation |
Symbiosis International University |
| Address |
Room No. 4, Department of Nutrition and Dietetics, Symbiosis School of Culinary Arts, Symbiosis International University, Lavale, Village, Taluka, Mulshi, Pune
Pune MAHARASHTRA 412115 India |
| Phone |
9874122419 |
| Fax |
|
| Email |
aninditaghosh29@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Arti Muley |
| Designation |
Assistant professor |
| Affiliation |
Symbiosis International University |
| Address |
Room No. 4, Department of Nutrition and Dietetics, Symbiosis School of Culinary Arts, Symbiosis International University, Lavale, Village, Taluka, Mulshi, Pune
Pune MAHARASHTRA 412115 India |
| Phone |
9874122419 |
| Fax |
|
| Email |
asstprofnd@ssca.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Anindita Ghosh |
| Designation |
PhD Scholar |
| Affiliation |
Symbiosis International University |
| Address |
Room No. 4, Department of Nutrition and Dietetics, Symbiosis School of Culinary Arts, Symbiosis International University, Lavale, Village, Taluka, Mulshi, Pune
Pune MAHARASHTRA 412112 India |
| Phone |
9874122419 |
| Fax |
|
| Email |
aninditaghosh29@gmail.com |
|
|
Source of Monetary or Material Support
|
| Symbiosis University Hospital & Research Centre
Dnyan Marg, Mulshi Rd, Lavale, Maharashtra 412115 |
|
|
Primary Sponsor
|
| Name |
Anindita Ghosh |
| Address |
Symbiosis International (Deemed University)
Gram: Lavale, Tal: Mulshi,
Dist: Pune, Maharashtra, India |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| DrArti Muley |
Symbiosis International (Deemed University), Lavale, Maharashtra 412115 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrGirish Kumthekar |
Symbiosis University Hospital & Research Centre |
Room No.104, Nephrology Unit, Department of Nephrology and Dialysis Division, Lavale, Mulli, Pune Pune MAHARASHTRA |
7032295272
girish.kumthekar@suhrc.siu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Symbiosis International (Deemed university)Institutional Ethics Committee (BHR)-II,SIU-Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N189||Chronic kidney disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Plant Dominant Low Protein Diet |
More than 50% plant-dominant, low-protein diet, oral for 3 months
|
| Comparator Agent |
Renal diet |
Standard renal diet , oral for 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Location: Pune district Maharashtra India
Food habits: Both vegetarian and non-vegetarian food habits.
Nutritional status :well-nourished to moderately malnourished (as per the SGA tool and nutrition focused physical exam)
Activity: light to medium physical activity
Willing to participate or consenting to the study
|
|
| ExclusionCriteria |
| Details |
Not diagnosed with CKD
Patient of CKD stage 4-5 (ESRD) with GFR (less than 30 mL/min/1.73 m²)
pediatric and geriatric population
Outside Pune district Maharashtra India,An acute or chronic communicable infection, pregnancy, lactation or any critical illness, heart disease, liver disease, cancer, Malabsorptive diseases like short bowel syndrome or Irritable bowel disease, continuous supportive dialysis care for management of the disease.
Severely malnourished nutritional status
Bed ridden; physically-mentally handicapped, dependent individuals
Unwilling to participate/not giving consent to the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in the nutritional status and dietary intake, frequency of the symptoms (Vomiting, diarrhea, nausea, anorexia, loss of appetite. Regulation of the renal biochemical parameters (Hemoglobin,E-GFR , Urine-albumin creatinine ratio, Uric acid, electrolytes,HbA1C,Blood pressure monitoring).Compliance and adherence rate to diet. |
4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Monitor the improvement in nutritional status,dietray intake after the initiation of plant dominant low protein diet
|
4 months |
|
|
Target Sample Size
|
Total Sample Size="200" Sample Size from India="200"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/07/2024 |
| 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="8" 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
|
The study titled "Effect of Plant Dominant Low Protein Diet among Chronic Kidney Disease Patients from Selected Hospitals in Pune, India - A Randomized Prospective Controlled Study" aims to investigate the impact of a plant-based low protein diet on patients with chronic kidney disease (CKD). Chronic kidney disease is a progressive condition characterized by gradual loss of kidney function, and dietary management plays a crucial role in slowing disease progression and managing symptoms. Summary: The trial involves chronic kidney disease patients from selected hospitals in Pune, India, who are randomized into two groups: one receiving a plant-dominant low protein diet and the other continuing with a standard diet. The study is prospective and controlled, meaning that patients are followed over time and their outcomes are compared between the two groups. Key measures include kidney function parameters, nutritional status, and dietray compliance and adherence. Purpose: The primary purpose of the study is to determine whether a plant-dominant low protein diet can significantly improve kidney function and overall health outcomes in CKD patients compared to a standard diet. This includes evaluating the effects on biochemical markers of kidney function, nutritional deficiencies,dietray intake, adherence and compliance to the diet . The study aims to provide evidence on the benefits and feasibility of implementing a plant-based dietary approach in the management of CKD, potentially offering a sustainable and beneficial dietary strategy for these patients.
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