| CTRI Number |
CTRI/2025/08/092512 [Registered on: 06/08/2025] Trial Registered Prospectively |
| Last Modified On: |
06/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of vitamin D supplementation on sarcopenia in sarcopenic end stage renal disease patients |
|
Scientific Title of Study
|
Effect of cholecalciferol supplementation on sarcopenia in sarcopenic end stage kidney disease patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Disha Arora |
| Designation |
Senior resident |
| Affiliation |
ABVIMS PGIMER DR RML HOSPITAL NEW DELHI |
| Address |
Nephrology Department
PGI Building third floor
New Delhi
DELHI
110001
India |
| Phone |
08416831418 |
| Fax |
|
| Email |
doctordisha14091994@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lalit Pursnani |
| Designation |
Professor |
| Affiliation |
ABVIMS RML HOSPITAL |
| Address |
Nephrology department
PGI Building third floor
New Delhi
DELHI
110001
India |
| Phone |
9958268930 |
| Fax |
|
| Email |
drlalitkpursnani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lalit Pursnani |
| Designation |
Professor |
| Affiliation |
ABVIMS RML HOSPITAL |
| Address |
Nephrology department
PGI building third floor
New Delhi
DELHI
110001
India |
| Phone |
9958268930 |
| Fax |
|
| Email |
drlalitkpursnani@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nephrology department, ABVIMS Dr. RML HOSPITAL, New Delhi pincode 110001 |
|
|
Primary Sponsor
|
| Name |
Dr Himansu Sekhar mahapatra |
| Address |
Room no 307, PGI building third floor |
| Type of Sponsor |
Government medical college |
|
|
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 Disha Arora |
ABVIMS Dr. R.M.L. HOSPITAL |
Nephrology department , third floor Type III, room no 303
New Delhi
DELHI |
8416831418
doctordisha14091994@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ATAL BIHARI VAJPAYEE INSTITUTE OF MEDICAL SCIENCES DR. RAM MANOHAR HOSPITAL NEW DELHI -11001 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N186||End stage renal disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cholecalciferol supplementation |
All sarcopenic end stage kidney patients with vitamin D levels 30-20 ng/ ml (insufficient) and 20 mg/ml(deficienct) will be supplemented with 60,000 international units of cholecalciferol for 12 weeks . All sarcopenic end stage renal disease patients who have normal vitamin d levels (30-60 ng/ ml) will be supplemented with 60,000 international units every 15 days for 12 weeks |
| Comparator Agent |
N/A |
N/A |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
End stage ren disease patients (ckd5 - dialysis and non dialysis patients) |
|
| ExclusionCriteria |
| Details |
Age more than 60 years, bedridden patients, patients with malignancy, HIV, tuberculosis, chronic liver disease , pregnant women, already taking vitamin D supplementation for last 3 months before study enrollment |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the effect of cholecalciferol supplementation on sarcopenia in sarcopenic end stage renal disease patients |
3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To estimate the prevalence of sarcopenia in end stage kidney disease patients, to determine risk factors like age, gender, diabetes, hypertension, coronary artery disease , different hormonal deficiency or excess associated with sarcopenia in end stage kidney disease patients, to study improvement in quality of life after supplementation of cholecalciferol in sarcopenic end stage kidney disease patients |
0 and 6 months |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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 |
|
Date of First Enrollment (India)
|
19/08/2025 |
| 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="6"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - doctordisha14091994@gmail.com
- For how long will this data be available start date provided 01-03-2024 and end date provided 31-01-2029?
Response (Others) -
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
In this study cholecalciferol will be supplemented in sarcopenic end stage renal disease patients and effect on improvement on sarcopenia will be seen . Vitamin d will be supplemented in 60,000 international units once weekly in vitamin d deficient patients for 12 weeks and those who have sufficient levels of vitamin d will be given 60,000 international units every 15 days for 12 weeks. at the end of 12 weeks, they will be reassessed for improvement in sarcopenia. Those who not improved will be given further 12 weeks of vitamin d supplementation as described above, patients whose vitamin d levels increases >80 ng/dl will be excluded from the study. Effect of vitamin D supplementation on quality of life will be studied at baseline and at the end of supplementation (0 ands 6 months). |