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The Effect of High-Dose Vitamin D Supplementation on Hand Grip Strength Recovery in Eldery patient with Distal Radius Fracture : A Double-blinded Randomized Controlled Trial

Phase 3
Conditions
Distal radius fracture
Distal radius fractureHypovitaminosis D
Elder
Distal radius fixation
Vitamin D supplementation
Registration Number
TCTR20240720001
Lead Sponsor
Siriraj hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending (Not yet recruiting)
Sex
All
Target Recruitment
106
Inclusion Criteria

1. Patients older than 60 years.
2. Have a distal radius fracture from a low-energy trauma and received surgical treatment using ORIF (Open Reduction and Internal Fixation) with plate and screws within 21 days post-injury.

Exclusion Criteria

1. History of receiving vitamin D within the past 6 months
2. Inflammatory joint diseases such as RA, SLE, or Gout
3. Abnormalities in bone metabolism, such as CKD beyond stage IV
4. Diagnosed with neuromuscular or neurosensory conditions affecting wrist function
5. History of using steroids within the past 12 months
6. History of injury or fracture or surgery in both wrists
7. Hand disease from both congenital and acquired in both wrists
8. Cognitive impairment
9. History of severe allergic reactions to vitamin D supplements

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Hand grip strength recovery at 6 months after surgery Jamar dynamometer
Secondary Outcome Measures
NameTimeMethod
Functional score 1 week, 6 week, 3 months, 6 months, 1 year Thai version of Patient-Rated Wrist Evaluation,Appendicular skeletal mass index (ASMI) 1 week, 6 week, 3 months, 6 months, 1 year dual-frequency bioelectrical impedance analysis,Vitamin D level 6 months electrochemiluminescence (ECL) binding assay,Radiographic alignment 1 week, 6 week, 3 months, 6 months, 1 year Intelli-Space PACS Enterprise (Philips)
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