| CTRI Number |
CTRI/2025/11/096804 [Registered on: 03/11/2025] Trial Registered Prospectively |
| Last Modified On: |
02/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
How Vitamin D3 and Calcium supplements affect bone healing after wrist fractures |
|
Scientific Title of Study
|
A Randomized Open Label three arm Trial To Compare Efficacy Of Oral Vitamin D3 Vs Oral Calcium Supplemented With Vitamin D3 and control arm with standard treatment without supplementation In Patients With Acute Distal Radius Fracture Healing In Tertia |
| 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. Alok Dixit |
| Designation |
Professor & Head of Department |
| Affiliation |
Uttar Pradesh University of Medical Sciences |
| Address |
Room No.305 ,Second floor,Department of Pharmacology,Academics building, UPUMS Medical College Saifai, Uttar Pradesh 206130
Etawah
UTTAR PRADESH
206130
India |
| Phone |
9639523852 |
| Fax |
|
| Email |
alkdxt@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Alok Dixit |
| Designation |
Professor & Head of Department |
| Affiliation |
UTTAR PRADESH UNIVERSITY OF MEDICAL SCIENCES |
| Address |
Room No.305,Second floor,Department of Pharmacology , Academic building, UPUMS MEDICAL COLLEGE SAIFAI, UTTAR PRADESH 206130
Etawah
UTTAR PRADESH
206130
India |
| Phone |
9639523852 |
| Fax |
|
| Email |
alkdxt@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Raghulraja |
| Designation |
Postgraduate Junior Resident |
| Affiliation |
Uttar Pradesh University of Medical Sciences |
| Address |
Room No.305,Second floor,Department of Pharmacology,Academics building, UPUMS Medical College Saifai, Uttar Pradesh 206130
Etawah
UTTAR PRADESH
206130
India |
| Phone |
9944407474 |
| Fax |
|
| Email |
raghulraja4393@gmail.com |
|
|
Source of Monetary or Material Support
|
| Uttar Pradesh University of Medical Sciences, Saifai, Etawah, Uttar Pradesh, India – Pin code 206130 |
|
|
Primary Sponsor
|
| Name |
UTTAR PRADESH UNIVERSITY OF MEDICAL SCIENCES |
| Address |
Uttar Pradesh University of Medical Sciences (UPUMS)
Saifai, Etawah, Uttar Pradesh 206130, India |
| 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 |
| Raghulraja |
Uttar Pradesh University of Medical Sciences Hospital |
Room no.7,Orthopedic OPD,Old OPD building, Uttar Pradesh ,Etawah, UTTAR PRADESH-206130
Etawah
UTTAR PRADESH |
09944407474
raghulraja4393@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee ,Uttar Pradesh University of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S629||Unspecified fracture of wrist andhand, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group I - Oral Vitamin D3
Group II- Oral Calcium with Vitamin D3
|
Group I- Participants will receive Oral Vitamin D3 1000 IU once daily per oral for 12 weeks, along with standard fracture management.
Group II-Participants will receive Oral Calcium 1 gm supplemented with Vitamin D3 1000 IU once daily per oral for 12 weeks, along with standard fracture management.
|
| Comparator Agent |
Group III-Control (Standard Treatment Arm) |
Group III- Participants will receive standard fracture management only, with no additional supplementation of Vitamin D3 or Calcium |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
closed , acute distal radius fractures within 1 week of injury with AO Classification Type A (extra-articular) fractures willing to provide consent |
|
| ExclusionCriteria |
| Details |
pathological fractures, active surgical intervention, systemic illness, possible drug causing interaction and altering actions, pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to evaluate radiological healing outcomes among the three groups |
Outcomes will be assessed among the three groups at baseline, 4 weeks & 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| funtional recovery using Disability of Arm , Shoulder & Hand Questionnaire |
Outcome will be assessed at baseline, 4 weeks & 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="99"
Sample Size from India="99"
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 2 |
|
Date of First Enrollment (India)
|
17/11/2025 |
| 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="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
|
SUMMARY A randomized, open-label, three-arm trial, the purpose of this study is to evaluate and compare the efficacy of oral vitamin D3, oral calcium supplemented with vitamin D3, and a control arm with standard treatment without supplementation on fracture healing in patients with acute distal radius fractures. Patients with acute distal radius fractures will be randomized into three groups: an oral vitamin D3 arm, an oral calcium with vitamin D3 arm, and a control group receiving no supplementation. Patients will be randomly assigned in a 1:1:1 ratio, with each group consisting of approximately equal participants.
Group I will receive oral vitamin D3 (1000 IU once daily). Group II will receive oral calcium (1 gm) supplemented with vitamin D3 (1000 IU) once daily. Group III (control arm) will receive standard fracture management without additional supplementation. Clinical and radiological assessments using X-rays will be conducted at day 0, 4 weeks, and 8 weeks, and CT-based scoring systems will be conducted at 12 weeks to monitor healing.
The primary outcome is radiographic healing assessed through standardized scoring systems. The secondary outcomes include clinical improvement in pain, functional scores, and any adverse drug effects. |