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Study aim
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1. Comparing union rate of distal radius fractures between the group receiving bolus vitamin D3 and the group receiving vitamin D3
2. Comparing complications such as non-union, union with deformity or infection between the two groups
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Design
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Randomized, parallel-group, unblinded, phase 1-2 clinical trial on 96 patients who, after entering the study, will be assigned to two groups in a permutation random block of 6.
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Settings and conduct
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In this study, patients with isolated distal radius fractures aged over fifty years and have undergone pcp with the less than 20 ng/dl of vitamin d3 is will be randomly assigned to two groups of 48 people. One group will be prescribed oral vitamin D3 tablets for six weeks, and the other group will be prescribed a 300,000 unit vitamin D3 ampoule, and both groups will be given daily calcium supplements. The results of the union in the two groups will be monitored for 12 weeks.
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Participants/Inclusion and exclusion criteria
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Patients diagnosed with Fernandez type 1 distal radius fracture who are over 50 years old and have undergone closed reduction and pcp.
Patient with other simultaneous fractures or with an old fracture in the same location or with any metabolic, neoplastic, or rheumatologic disease, or with any cytotoxic ,hormonal or supplemental drug history will be excluded from the study.
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Intervention groups
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Both groups undergo closed pin fixation. In one group, vitamin D3 supplementation is given daily in tablets and in the other group, in bolus form in ampoules. Both groups are given equal amounts of oral calcium in tablets.
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Main outcome variables
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The intended outcome is the time to complete fracture union (based on radiological and clinical criteria), which includes the following:
Radiological: Formation of bone callus on all 4 sides of the fracture
Clinical: No pain with direct pressure + no movement at the fracture site by week 12 after treatment