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 Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Enrollment
- 99
- Locations
- 1
- Primary Endpoint
- to evaluate radiological healing outcomes among the three groups
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 40.00 Year(s) to 70.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •closed , acute distal radius fractures within 1 week of injury with AO Classification Type A (extra-articular) fractures willing to provide consent.
Exclusion Criteria
- •pathological fractures, active surgical intervention, systemic illness, possible drug causing interaction and altering actions, pregnant and lactating women.
Outcomes
Primary Outcomes
to evaluate radiological healing outcomes among the three groups
Time Frame: Outcomes will be assessed among the three groups at baseline, 4 weeks & 8 weeks
Secondary Outcomes
- funtional recovery using Disability of Arm , Shoulder & Hand Questionnaire(Outcome will be assessed at baseline, 4 weeks & 8 weeks)
Investigators
Dr. Alok Dixit
Uttar Pradesh University of Medical Sciences