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CTRI Number  CTRI/2022/04/041763 [Registered on: 11/04/2022] Trial Registered Prospectively
Last Modified On: 24/06/2022
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Nutraceutical 
Study Design  Other 
Public Title of Study   Nutritional Supplement Study in Chronic Kidney Disease Patients who are on dialysis. 
Scientific Title of Study   A single-arm, prospective study to evaluate the effects of oral nutritional supplementation in chronic kidney disease (CKD) patients on maintenance hemodialysis (MHD) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rahul Rathod 
Designation  Head - Ideation and Clinical Research 
Affiliation  Dr Reddys Laboratories Ltd  
Address  Medical Affairs Department, Dr Reddys Laboratories Ltd, 7-1-27, Ameerpet, Hyderabad

Hyderabad
TELANGANA
500016
India 
Phone  04049048400   
Fax  04049048800   
Email  Rahul.Rathod@drreddys.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rahul Rathod 
Designation  Head - Ideation and Clinical Research 
Affiliation  Dr Reddys Laboratories Ltd  
Address  Medical Affairs Department, Dr Reddys Laboratories Ltd, 7-1-27, Ameerpet, Hyderabad

Hyderabad
TELANGANA
500016
India 
Phone  04049048400   
Fax  04049048800   
Email  Rahul.Rathod@drreddys.com  
 
Details of Contact Person
Public Query  
Name  Dr Rahul Rathod 
Designation  Head - Ideation and Clinical Research 
Affiliation  Dr Reddys Laboratories Ltd  
Address  Medical Affairs Department, Dr Reddys Laboratories Ltd, 7-1-27, Ameerpet, Hyderabad

Hyderabad
TELANGANA
500016
India 
Phone  04049048400   
Fax  04049048800   
Email  Rahul.Rathod@drreddys.com  
 
Source of Monetary or Material Support  
Dr Reddys Laboratories Medical Affairs Department, Dr Reddy Laboratories Ltd, 7-1-27, Ameerpet Road, Ameerpet, Hyderabad Hyderabad TELANGANA 500016 India 
 
Primary Sponsor  
Name  Dr Reddys Laboratories 
Address  7-1-27, Ameerpet Hyderabad 500016  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Arun Shah  BAN Hospital  First floor dialysis unit, N.S. Road No.13, JVPD Scheme, Juhu
Mumbai
MAHARASHTRA 		 9821133935

drarunshah56@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Suraksha Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N189||Chronic kidney disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  CELEVIDA MAXX DLS (Oral Nutrition Supplement)  For 1 serve mix 40g of powder with 180ml of water Oral administration 
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1) Age ≥ 18 years
2) Subjects on maintenance hemodialysis diagnosed as malnourished (serum albumin concentration <4 g/dL and/or a loss of ≥ 5% dry weight [DW] over the past 3 months)
3)Body weight history of past 6 months
4)Subjects willing to participate in the study
5)Subjects willing to consume the nutritional drink as per the protocol 
 
ExclusionCriteria 
Details  1)Patients with recurrent acute illnesses
2)Body weight less than 40 kg
3)Documented history of dialysis noncompliance
4)Documented malabsorption syndromes
5)Chronic inflammatory diseases of unknown origin
6)Recent surgery within 3 months or during follow-up
7)Contraindications to any of the ingredients of the nutritional supplement
8)Major cardiovascular event, or death during follow-up;
9)Patients with nephrotic syndrome;
10)Patients with history of malignancy
11)Chronic liver disease
12)Pregnant and lactating women.
13)Patient taking any other nutritional supplement 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To evaluate the effect of oral nutraceutical supplementation on the protein levels (change in serum albumin concentration) in patients with CKD on maintenance dialysis.  Screening/Basline (Visit 1), Month 1 Follow up(Visit 2), Month 2 Follow up (Visit 3) Month 3 End of study (Visit 4) 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the nutritional status using 24-hour dietary recall, modified subjective global assessment from baseline to 3 months.
1. To assess the risk of malnutrition using hand grip strength from baseline to 3 months.
2. To assess the inflammation levels due to malnutrition using malnutrition inflammation score from baseline to 3 months.
3. To assess the rate of Protein-energy wasting (PEW) using anthropometric values; i.e., Body weight, Body Mass Index, Triceps skin fold thickness from baseline to 3 months.
4. To assess the rate of iron loss using hemoglobin levels from baseline to 3 months.
5. To assess the rate of recovery from malnutrition using serum pre-albumin levels from baseline to 3 months.
6. To assess whether the serum potassium and phosphorous levels are maintained from baseline to 3 months in patients with CKD on maintenance dialysis. 		 Screening/Basline (Visit 1), Month 1 Follow up(Visit 2), Month 2 Follow up (Visit 3) Month 3 End of study (Visit 4) 
 
Target Sample Size   Total Sample Size="78"
Sample Size from India="78" 
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   11/04/2022 
Date of Study Completion (India) 22/06/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 22/06/2022 
Estimated Duration of Trial   Years="0"
Months="11"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   This study is an single-arm, Single center, prospective study to evaluate the effect of oral nutraceutical supplementation on the protein levels when given twice daily for 3 months in 78 patients (≥ 18 years) with Chronic kidney disease (CKD) on maintenance hemodialysis (MHD) that will be conducted in India. The primary endpoint will be change in serum albumin concentration and the secondary endpoint will be change in 24-hour dietary recall in patients over the study period (3 months) in patients with CKD on maintenance dialysis.  
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