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IRCT20260629070011N1 IRCT 2026-07-24 Arak University of Medical Sciences The comparison between bolus and daily vitamin D3 supplementation in distal radius fracture The comparison between bolus and daily vitamin D3 supplementation in distal radius fracture 2026-07-23 anticipated 96 Complete https://irct.ir/trial/91309 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this clinical trial, participants will be randomly assigned to two groups after entering the study in a permutation block of 6. The first group will receive injectable vitamin D3 and the second group will receive oral vitamin D3. After obtaining informed consent and confirming the inclusion criteria, the patient's basic information will be recorded and the patient will be placed in the relevant stratum. Group assignment will be based on a pre-generated sequence. All steps will be performed by a research assistant who is not involved in the intervention. This method ensures that the assignment of patients to groups is completely random and free from bias. 3 distal radius fracture. Intervention 1: Intervention Group: Approximately half of the patients in the study (about 48 patients) will undergo closed reduction and percutaneous pin fixation for their fracture. They will then receive vitamin D3 as a bolus via intramuscular injection. Patients will also receive oral calcium supplements in tablet form. All medications are manufactured in Iran and no specific brand will be imposed on the patients. The patients will then be followed up for 12 weeks, and the results regarding fracture union will be compared with the control group. Intervention 2: Control Group: Approximately half of the patients in the study (about 48 patients) will undergo closed reduction and percutaneous pin fixation for their fracture. They will then receive vitamin D3 orally as a daily tablet. Patients will also receive oral calcium supplements in tablet form. All medications are manufactured in Iran and no specific brand will be imposed on the patients. The patients will then be followed up for 12 weeks, and the results regarding fracture union will be compared with the intervention group. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Arash Rashidi
Armaghan Ally, Nabovat Avenue , Urmia city
Urmia Iran (Islamic Republic of) 5719915883 +98 918 873 8198 Arashrashidi20@gmail.com Arak University of Medical Sciences scientific Arash Rashidi
Armaghan Ally, Nabovat Avenue , Urmia city
Urmia Iran (Islamic Republic of) 5719915883 +98 918 873 8198 Arashrashidi20@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) patients with distal radius fracture aged at least 50 years patients with type 1 Fenrandez classification managed by pcp 50 years no limit Both patients with simultaneous fractures in other bones of body are rolled out from the study patients with old fracture in the same place are rolled out from the study patients with chronic metabolic or neoplastic or rheumatologic diseases are rolled out from the study patients with history of cytotoxic or hormonal or supplementation drug consumption are rolled out of the study S52.5 Fracture of lower end of radius Treatment - Drugs Treatment - Drugs Intervention Group: Approximately half of the patients in the study (about 48 patients) will undergo closed reduction and percutaneous pin fixation for their fracture. They will then receive vitamin D3 as a bolus via intramuscular injection. Patients will also receive oral calcium supplements in tablet form. All medications are manufactured in Iran and no specific brand will be imposed on the patients. The patients will then be followed up for 12 weeks, and the results regarding fracture union will be compared with the control group. Control Group: Approximately half of the patients in the study (about 48 patients) will undergo closed reduction and percutaneous pin fixation for their fracture. They will then receive vitamin D3 orally as a daily tablet. Patients will also receive oral calcium supplements in tablet form. All medications are manufactured in Iran and no specific brand will be imposed on the patients. The patients will then be followed up for 12 weeks, and the results regarding fracture union will be compared with the intervention group. The time of complete fracture union (based on radiological and clinical criteria). Timepoint: 4th and 12th weeks after fixation. Method of measurement: Radiological: Formation of bone callus on 4 sides of the fracture and Clinical: No pain with direct pressure + no movement at the fracture site until 12 weeks after treatment. Arak University of Medical Sciences Approved 2026-06-14 ethic committee of Arak University of Medical sciences Armaghan Ally, Nabovat Avenue , Urmia city Urmia West Azarbaijan Iran (Islamic Republic of)