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IRCT20241215064055N1 IRCT 2024-12-20 Oroumia University of Medical Sciences Comparison of the high dose and conventional regimen of vitamin D effect on antioxidant markers of patients with diabetic foot ulcer Comparison of the high dose and conventional regimen of vitamin D effect on antioxidant markers of patients with diabetic foot ulcer 2025-01-04 anticipated 50 Complete https://irct.ir/trial/80769 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 50 patients will be individually divided into two groups using the Block randomization method based on numbers generated by the random allocation software. 3 diabetic foot ulcer. Intervention 1: Intervention group: First (Recipients of three doses of 50,000 IU vitamin D pearls). Intervention 2: Intervention group: Second (Recipients of a single dose of 300,000 IU vitamin D injection). Yes - There is a plan to make this available What will be shared: All data can potentially be shared after individuals are made unidentifiable. When: Access begins 6 months after the publication of results. To whom: Researchers working in academic and scientific institutions. Conditions: . Where to obtain: Email address: Rozita.salehi@ymail.com How to obtain: The applicant must state the reason for their need for the data and how they will use the data via email. The result will be communicated to them within a week. Comments:
public Rozita Salehi sadaqiani
No. 288, Emam Ali Blvd
Urmia Iran (Islamic Republic of) 5719633333 +98 44 3343 7522 www.rozita.salehi@ymail.com Oroumia University of Medical Sciences scientific Rozita Salehi sadaqiani
No. 288, Emam Ali Blvd
Urmia Iran (Islamic Republic of) 5719633333 +98 44 3343 7522 www.rozita.salehi@ymail.com Oroumia University of Medical Sciences Iran (Islamic Republic of) plasma calcium level less than 10 vitamin D level in between 20-30 ng/ml age more than 18 years old Diabetic foot ulcer grade 3 and 4 by wagner classification Obtaining informed consent from patients platelet count more than 100000 18 years no limit Both Sensitivity to vitamin D products Known diseases associated with hypercalcemia Pregnancy and breastfeeding Primary hyperparathyroidism Patients undergoing treatment with chemotherapy or radiotherapy Use of medications that interfere with wound healing, such as: chronic use of corticosteroids (minimum equivalent dose of 40 mg of prednisone), mycophenolate, cyclosporine, tacrolimus, rituximab. Patients with severe renal failure, GFR less than 30 mL per minute. Platelet count less than 100,000, in the time of intramuscular injection of the ampoule. Hospitalization for diabetic foot ulcers in the past month Administration of injectable antibiotics for diabetic foot ulcers in the past month. Stenosis and severe occlusion of the lower limb vessels based on vascular ultrasound. Chronic alcohol consumption of more than 250 cc daily. Presence of other concurrent disorders or infections. E11.621 Type 2 diabetes mellitus with foot ulcer Treatment - Drugs Treatment - Drugs Intervention group: First (Recipients of three doses of 50,000 IU vitamin D pearls) Intervention group: Second (Recipients of a single dose of 300,000 IU vitamin D injection) Total Antioxidant Capacity. Timepoint: Before the intervention and 21 days after the intervention. Method of measurement: Based on the kit used in the laboratory. Blood Malondialdehyde Level. Timepoint: Before the intervention and 21 days after the intervention. Method of measurement: Based on the kit used in the laboratory. Blood Nitric Oxide Level. Timepoint: Before the intervention and 21 days after the intervention. Method of measurement: Based on the kit used in the laboratory. Maximum Erythrocyte Sedimentation Rate (ESR) level in Millimeters per Hour. Timepoint: Before the intervention and 21 days after the intervention. Method of measurement: Based on the kit used in the laboratory. The highest concentration of C-reactive protein (CRP) in blood is measured in milligrams per liter. Timepoint: Before the intervention and 21 days after the intervention. Method of measurement: Based on the kit used in the laboratory. Oroumia University of Medical Sciences Approved 2024-10-23 Ethics Committee/Working Group in Research at Imam Khomeini Educational and Medical Center - Urmia U Imam Khomeini Hospital, Ershad Blvd Urmia West Azarbaijan Iran (Islamic Republic of)