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

Not yet recruiting

• Conditions: Subjects with CKD stage III and IV and GFR – 20 – 45 ml/min, Co morbid conditions – Hypertension

• Registration Number: CTRI/2017/04/008442
• Lead Sponsor: Sri Ramachandra University

Brief Summary

**Need for the study**

 Nutritiontherapy forms a very important component in management of renal disease.Subjects with Renal Disease are posed with a lot of dietary restrictions whichleads to psychological stress. In spite of these restrictions the progressionof kidney disease ultimately leading to End Stage Renal Disease are high. Dietarycounseling for CKD patients is complex and patients are frequently confused bythe multitude of recommendations. There are no human clinical trials that haveclearly demonstrated that lowering dietary phosphate absorption in patientswith normal phosphorus levels. Grain based vegetarian diets reported to havedecreased phosphorus absorption compared with meat or casein based diets.**(Sharon et al. 2011).** These authorshave highlighted the need for larger studies demonstrating the feasibility of astructured dietary exposure approach to give appropriate recommendations.

 **Aim/Broad Objective**

ü  The study aims at developing anindividualized dietary plan and evaluate its influence on the renal parametersof subjects with chronic disease and based on the outcome, develop an evidencebased dietary plan mobile application for use by the subjects with chronickidney disease.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-05
• Last Update Posted: 2017-04-28

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To Correlate renal specific nutrient intake with renal biochemical parameters like BUN, Creatinine, Sodium, Potassium and Phosphorus	One week

Secondary Outcome Measures

Name	Time	Method
To develop a database and create a mobile app on renal nutrition	Six to Eight Months

Trial Locations

Locations (1)

Sri Ramachandra University; 🇮🇳 Kancheepuram, TAMIL NADU, India

Sri Ramachandra University

🇮🇳Kancheepuram, TAMIL NADU, India

Dr P Soundararajan

Principal investigator

9884984602

abhinayassrao@gmail.com