| CTRI Number |
CTRI/2026/02/102705 [Registered on: 02/02/2026] Trial Registered Prospectively |
| Last Modified On: |
01/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Randomized Controlled Trial Comparing the Efficacy and Safety of Cholecalciferol versus Calcitriol in CKD-MBD Patients with Vitamin D
deficiency. |
|
Scientific Title of Study
|
A Randomized Controlled Trial Comparing the Efficacy and Safety of Cholecalciferol versus Calcitriol in CKD-MBD Patients with Vitamin D
deficiency. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aman Chaudhary |
| Designation |
Junior Resident |
| Affiliation |
PGIMER Chandigarh |
| Address |
Department of Internal medicine PGIMER Chandigarh
Sector 11
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9780214155 |
| Fax |
|
| Email |
abcdaman36@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Smita Divyaveer |
| Designation |
Additional Professor |
| Affiliation |
PGIMER Chandigarh |
| Address |
Department of Nephrology PGIMER CHNADIGARH
sector 11
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8017062986 |
| Fax |
|
| Email |
Divyaveer.ss@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aman Chaudhary |
| Designation |
Junior Resident |
| Affiliation |
PGIMER Chandigarh |
| Address |
department of Internal medicine, PGIMER CHD
sector 11
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9780214155 |
| Fax |
|
| Email |
abcdaman36@gmail.com |
|
|
Source of Monetary or Material Support
|
| department of Nephrology, PGIMER Chandigarh, 160012 |
|
|
Primary Sponsor
|
| Name |
PGIMER |
| Address |
Department of Nephrology, PGIMER Chandigarh, 160012 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Aman Chaudhary |
Nephrology clinic PGIMER chandigarh |
Post graduate institute of medical education and research, Chandigarh
Chandigarh
CHANDIGARH |
09780214155
abcdaman36@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional-ethics-committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E559||Vitamin D deficiency, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Safety and efficacy of Calcitriol vs Cholecalciferol in CKD-MBD patients |
Not applicable |
| Intervention |
Safety and efficacy of Calcitriol vs Cholecalciferol in CKD-MBD patients |
The proposed research introduces a novel comparative framework by conducting a
randomized controlled trial specifically evaluating the efficacy and safety of cholecalciferol
versus calcitriol in vitamin D-deficient CKD-MBD patients. Unlike previous investigations
that have primarily focused on the individual effects of these drugs, this study aims to
perform a direct comparison, particularly focusing on bone turnover markers and key
biochemical endpoints. Such a comparative trial in this specific subgroup remains scarce in
current literature. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
CKD Stage 3 to 5 (not on dialysis)
Serum 25(OH) D levels less than 20ng/mL
Clinical or biochemical evidence of CKD-MBD |
|
| ExclusionCriteria |
| Details |
Serum calcium more than 10.5 mg/dL
Serum iPTH less than 15 pg/mL
History of parathyroidectomy
Presence of bone diseases unrelated to CKD (e.g., multiple myeloma, bone metastases)
Use of immunosuppressive drugs
Diagnosed immune-mediated disorders (e.g., systemic lupus erythematosus, sarcoidosis)
Critically ill or moribund patients
Malabsorption syndrome
Sepsis
Malignancy
Pregnancy or lactation
Patients unable to take oral medications
Patients not providing consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Rise or change in serum 25 hydroxy vitamin D and active 1,25 dihydroxy vitamin D levels at the 3 month point.
The pattern of change in bone formation markers particularly, BS-ALP and Serum P1NP.
How often patients experience elevated calcium or phosphate levels on either therapy.
Whether intact parathyroid hormone (iPTH) levels show meaningful improvement with
either treatment. |
0,1,2,3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the change in bone turnover markers (BS-ALP and S-P1NP) over a period of 3 months
3 months.
To determine the incidence of hypercalcemia and hyperphosphatemia in both treatment
groups.
To assess the change in serum intact parathyroid hormone (iPTH) levels from baseline to
3 months. |
0, 1, 2, 3 months |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
15/02/2026 |
| 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 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
|
Despite widespread use of both cholecalciferol and calcitriol in managing vitamin D deficiency among patients with Chronic Kidney Disease-Mineral and Bone Disorder (CKDMBD), there is a lack of robust randomized controlled trials (RCTs) directly comparing their efficacy and safety. Particularly, limited data are available regarding their effect on vitamin D metabolites and bone-specific biochemical markers in this patient population. This evidence gap hinders clinical decision-making in choosing the optimal form of vitamin D therapy in CKD-MBD.
|