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IRCT20190202042588N2 IRCT 2021-01-22 Shahid Beheshti University of Medical Sciences Evaluation of the relationship between vitamin D3 and hemoglobin in patients undergoing hemodialysis Correlation between vitamin D3 and rise of hemoglobin in dialysis in hemodialysis ward 2021-02-18 anticipated 60 Complete https://irct.ir/trial/51887 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: For this purpose, the random allocation role method will be used. For this purpose, the letter A (drug identifier) will be written on 30 sheets of paper and all letters B will be written on the other 30 papers. It is closed and placed inside the box, then the papers will be randomly removed from the box for each patient without replacement and the created sequence will be recorded, Blinding description: The study is three-blind Drugs and placebos, which are completely similar in shape and packaging and made by Tehran Drug Company, will be written on one A and on one B, and the nurse will not know if the drug or placebo is the same, and the patient will not know about the drug and Or will not know if it is a placebo and after testing the patient information will be delivered to the analyzer in two groups with numbers one and two. 2-3 Anemia in chronic kidney disease. Intervention 1: Intervention group: Thirty patients underwent hemodialysis for 6 months, and for the treatment of anemia during these six months, they were treated with Aprex 4000 ampoules three times a week subcutaneously with 100 mg Venofer ampoules from soha daroo at least twice a week. Vitamin D is less than 30 ng / dl. First, the concentration of hemoglobin, calcium, phosphorus, parathyroid hormone, C-reactive protein, iron, Total iron-binding capacity, ferritin and vitamin D levels are checked. Then, treated with Tehran darou vitamin D, we give 50,000 oral units once a week for three months. Will be taken. Intervention 2: Control group: 30 patients who have undergone hemodialysis for 6 months, and for the treatment of anemia in these six months, treated with Aprex ampoule 4000 units three times a week subcutaneously with 100 mg Venofer ampoule of Saha Kish company at least twice a week and despite complete iron storage is still anemic And vitamin D levels are less than 30 ng / dl. First, the concentration of hemoglobin, calcium, phosphorus, parathyroid hormone, C-reactive protein and iron, total iron-binding capacity, ferritin and vitamin D levels are checked . Then we are treated with placebo from Tehran Daroo Company once a week for three months And vitamin D and other tests will be measured three months later. Yes - There is a plan to make this available What will be shared: The whole potential data after being unidentifiable is published When: From 1400 To whom: Medical Society Conditions: Contributing to studies Where to obtain: sarasalarian@sbmu.ac.ir How to obtain: two months Comments:
public Sara Salarian
Shahid Madani Str
Tehran Iran (Islamic Republic of) 1617763141 +98 21 7755 8001 sarasalarian@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Sara Salarian
Shahid Madani Str
Tehran Iran (Islamic Republic of) 1617763141 +98 21 7755 8001 sarasalarian@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Age over 18 years Patients undergoing dialysis more than or equal to 3 times a week for more than or equal to 90 days Receive standard treatment for anemia (erythropoietin and Venofer ampoules) for at least three months Life expectancy of more than 6 months Absence of gastrointestinal disease or surgery that affects the absorption of vitamin D. Intact Parathyroid Hormone(IPTH)= 150-350pg/ml 18 years 80 years Both Hemoglobinopathy Chronic liver disease Dissatisfaction of patient companions Patients who do not return one month later pregnancy Dialysis adequacy is less than 1.4 in the last three months Transfusion over the past three months Hypercalcemia over the past month (> 10) Hyperphosphatemia over the past month (> 5) D63.1 Anemia in chronic kidney disease Treatment - Drugs Placebo Intervention group: Thirty patients underwent hemodialysis for 6 months, and for the treatment of anemia during these six months, they were treated with Aprex 4000 ampoules three times a week subcutaneously with 100 mg Venofer ampoules from soha daroo at least twice a week. Vitamin D is less than 30 ng / dl. First, the concentration of hemoglobin, calcium, phosphorus, parathyroid hormone, C-reactive protein, iron, Total iron-binding capacity, ferritin and vitamin D levels are checked. Then, treated with Tehran darou vitamin D, we give 50,000 oral units once a week for three months. Will be taken Control group: 30 patients who have undergone hemodialysis for 6 months, and for the treatment of anemia in these six months, treated with Aprex ampoule 4000 units three times a week subcutaneously with 100 mg Venofer ampoule of Saha Kish company at least twice a week and despite complete iron storage is still anemic And vitamin D levels are less than 30 ng / dl. First, the concentration of hemoglobin, calcium, phosphorus, parathyroid hormone, C-reactive protein and iron, total iron-binding capacity, ferritin and vitamin D levels are checked . Then we are treated with placebo from Tehran Daroo Company once a week for three months And vitamin D and other tests will be measured three months later Hemoglobin level. Timepoint: One and three months after the start of the trial. Method of measurement: Complete Blood Count. Shahid Beheshti University of Medical Sciences Approved 2020-08-08 Ethics committee of ُShahid Beheshti University of Medical Sciences Imam Hossein Hospital, Madani Str, Tehran, Iran. Post Code Tehran Tehran Iran (Islamic Republic of)