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CTRI Number  CTRI/2024/11/076859 [Registered on: 18/11/2024] Trial Registered Prospectively
Last Modified On: 11/11/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   Effects of Vitamin D3 in Patients of Chronic Kidney Disease with Vitamin D Deficiency and Secondary Hyperparathyroidism 
Scientific Title of Study   Safety and Efficacy of Cholecalciferol Supplementation in Patients of Chronic Kidney Disease (CKD) with Vitamin D Deficiency and Secondary Hyperparathyroidism (SHPT) 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
SHPT 03 2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr D Sreebhushan Raju 
Designation  Senior Professor and Unit Head 
Affiliation  Nizams Institute of Medical Sciences 
Address  Department of Nephrology roomno 299 Millineum block NIMS punjagutta Hyderabad

Hyderabad
TELANGANA
500082
India 
Phone  9030292929  
Fax    
Email  sreebhushan@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr D Sreebhushan Raju 
Designation  Senior Professor and Unit Head 
Affiliation  Nizams Institute of Medical Sciences 
Address  Department of Nephrology roomno 299 Millineum block NIMS punjagutta Hyderabad

Hyderabad
TELANGANA
500082
India 
Phone  9030292929  
Fax    
Email  sreebhushan@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Dr D Sreebhushan Raju 
Designation  Senior Professor and Unit Head 
Affiliation  Nizams Institute of Medical Sciences 
Address  Department of Nephrology roomno 299 Millineum block NIMS punjagutta Hyderabad

Hyderabad
TELANGANA
500082
India 
Phone  9030292929  
Fax    
Email  sreebhushan@hotmail.com  
 
Source of Monetary or Material Support  
Pulse Pharmaceuticals Pvt Ltd plot no 18/1 sector 3 HUDA techno enclave HITEC city Hyderabad Telangana 500081 India will provide with gift samples of Vitamin D3 60000 IU nano syrup 
 
Primary Sponsor  
Name  Nizams Institute of Medical Sciences 
Address  Department of Nephrology NIMS Punjagutta Hyderabad Telangana 500082 India 
Type of Sponsor  Government medical college 
 
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 D Sree Bhushan Raju  Nizams Institute of Medical Sciences  Departement of nephrology Room no 299 Millenium block NIMS Punjagutta Hyderabad
Hyderabad
TELANGANA 		 9030292929

sreebhushan@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Nizams Institutional Ethics Commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N258||Other disorders resulting from impaired renal tubular function,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Deksel Vitamin D3 60000 IU  Each subject will take 5ml of Cholecalciferol Vitamin D3 60000 IU Syrup every day for 10 days Thereafter from 15th day onwards a single 5ml dose of the same syrup to be taken every 15 days as maintenance therapy for 3-months On completion of 3rd month an interim analysis would be conducted subjects would be divided in the following 2 groups Group A Patients who achieve a serum PTH of less than equal to 70 pg per ml will continue with the same fortnightly i.e. every 15th day dose of Cholecalciferol Vitamin D3 Syrup 60000 IU for the rest of the trial period the remaining 3 months Group B Patients who record a serum PTH of greater than 70 pg per ml will be assigned to dose escalation group and will be administered an escalated weekly dose of Cholecalciferol Vitamin D3 60000 IU syrup i.e. one dose every week for the rest of the trial period the remaining 3 months  
Comparator Agent  Not applicable  Not applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  1 Age between 18 and 85 years
2 Those with an eGFR of greater than or equal to 15 and less than or equal to 59 mlmin1.73m2 CKD Grade 3 and 4
3 Serum total 25hydroxy D greater than or equal to 10 to less than or equal to 20 ng per ml
4 Plasma iPTH levels greater than or equal to 85 to less than 500 pg per ml
5 Serum Calcium of greater than or equal to 8.4 to less than 9.8 mg per dl
6 Serum Phosphorus of greater than or equal to 2 to less than 5 mg per dl
7 Patients are required to have language competency English Telugu or Hindi in order to complete the study related questionnaires which include the Beck Depression Inventory Questionnaire that measures characteristic attitudes and symptoms of depression
8 Normal Liver function test
9 A record will be made of the patients history and physical examination
10 Subject and legally acceptable representative LAR are able to attend all scheduled visits and to comply with all trial procedures
11 All patients will provide signed informed consent
 
 
ExclusionCriteria 
Details  1 Not available for follow-up
2 Allergic to or intolerant to the investigational medication
3 Fasting Spot urinary Ca:Cr ratio greater than 0.2
4 Nephrotic range proteinuria greater than equal to 3.5 g per 24h urine
5 History of parathyroidectomy or renal transplantation
6 Subjects taking greater than 1000 mg per day of elemental Ca
7 Subjects receiving supplementation with ergocalciferol or cholecalciferol
8 Any bone metabolism therapy with the exception of bisphosphonates that could potentially interfere with study endpoints is to be discontinued for the duration of the study and a 56 day pre treatment washout is to be imposed In the case of bisphosphonates, subjects had to be on a stable dose for greater than 6 months prior to enrolment and maintain that dose for study duration
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Number or percent of subjects achieving mean percent reductions of plasma iPTH of greater than equal to 30 percent from pre treatment baseline at the end of the study
Number of subjects with any adverse drug reaction
Number of subjects with serum 25HydroxyD levels of greater than equal to 150 ng per ml
Number of subjects with serum Ca levels of greater than equal to 10.5 mg per dl
Number of subjects with serum P of greater than 5.0 mg per dl 		 Screening Baseline Day 1 Day 30 Day 60 Day 90 Day 180 
 
Secondary Outcome  
Outcome  TimePoints 

Number or percentage of individuals with a 25hydroxy D levels of greater than equal to 30 ng per ml
Number or percentage of individuals requiring dose escalation after 3 months of treatment
Number of deaths during the study period 		 Screening Baseline Day 1 Day 30 Day 60 Day 90 Day 180 
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
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 3/ Phase 4 
Date of First Enrollment (India)   09/12/2024 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Safety and Efficacy of Cholecalciferol Supplementation in Patients of Chronic Kidney Disease with Vitamin D Deficiency and Secondary Hyperparathyroidism Prospective open label single center study

 
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