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IRCT20221217056845N1 IRCT 2023-03-04 Gorgan University of Medical Sciences the effect of vitamin K supplementation on bone factors in hemodialysis patients Investigating the effect of vitamin K supplementation on bone factors in hemodialysis patients 2023-01-05 anticipated 72 Complete https://irct.ir/trial/67521 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible patients were assigned to experimental and control groups using the random block method. For random allocation using blocks of 4, first by throwing 18 regular hexagons, a random sequence of 18 blocks of 4 was generated from among the following blocks: AABB-ABAB-ABBA-BAAB-BABA-BBAA In the desired sequence, there will be 37 of each letter A and B. According to the above block, 72 envelopes were prepared and the letter A or B was placed in each envelope and numbered from 1 to 72. 2-3 Patients with ESRD undergoing hemodialysis. Intervention 1: Intervention group: Calcium-D capsule (Shefa company contains 500 mg calcium and 200 IU vitamin D) along with vitamin K2 tablets (capsule containing vitamin K2-7, microcrystalline, cellulose, colloidal silicon dioxide, magnesium stearate) three times in daily for 8 weeks. Intervention 2: Control group: They receive calcium-D capsules three times a day for 8 weeks and placebo tablets with the same packaging and shape as vitamin K2 capsules. Yes - There is a plan to make this available What will be shared: The level of variables before and after the study / age of the patient / duration of dialysis and sex are informed When: Start the access period 6 months after printing results To whom: For researchers working in academic and scientific institutions Conditions: request and submission of usage documentation in new studies Where to obtain: Golestan University of Medical Sciences / Gorgan - Hirkan Blvd - Golestan University of Medical Sciences / 01732430310 / pr-5azar@goums.ac.ir How to obtain: The applicant will access within 1 month Comments:
public Sedighe Maghsoudloo
Bahman Alley 5,Saqai Alley 6,Afsaran Blvd,AfsaranTown, Gorgan City
Gorgan Iran (Islamic Republic of) 49178677439 +98 17 3246 0722 roya_sissy200@yahoo.com Gorgan University of Medical Sciences scientific Sedighe Maghsoudloo
Bahman Alley 5,Saqai Alley 6,Afsaran Blvd,AfsaranTown, Gorgan City
Gorgan Iran (Islamic Republic of) 49178677439 +98 17 3246 0722 roya_sissy200@yahoo.com Gorgan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Not using anticoagulant drugs age 18-75 years patient with ESRD and hemodialysis patients that dialyses > 1 months. 18 years 75 years Both Coagulation disorder Lack of consent to study Hypocalcemia or hypercalcemia in patients Infection before and during treatment with High CRP Using of antibiotic drugs Using of osteoporosis drugs lack of medication compliance I12.0 Hypertensive chronic kidney disease with stage 5 chronic kidney disease or end stage renal disease Treatment - Drugs Treatment - Drugs Intervention group: Calcium-D capsule (Shefa company contains 500 mg calcium and 200 IU vitamin D) along with vitamin K2 tablets (capsule containing vitamin K2-7, microcrystalline, cellulose, colloidal silicon dioxide, magnesium stearate) three times in daily for 8 weeks Control group: They receive calcium-D capsules three times a day for 8 weeks and placebo tablets with the same packaging and shape as vitamin K2 capsules. Comparison of the average serum levels of albumin after the implementation of the intervention. Timepoint: At the beginning of the study and 3 month later. Method of measurement: blood sample. Comparison of the average serum levels of calcium after the implementation of the intervention. Timepoint: At the beginning of the study and 3 month later. Method of measurement: blood sample. Comparison of the average serum levels of phosphorus after the implementation of the intervention. Timepoint: At the beginning of the study and 3 month later. Method of measurement: blood sample. Comparison of the average serum levels of Vitamin D after the implementation of the intervention. Timepoint: At the beginning of the study and 3 month later. Method of measurement: blood sample. Comparison of the mean serum PTH level after the implementation of the intervention to the basic value. Timepoint: At the beginning of the study and 3 month later. Method of measurement: blood sample. Comparison of the mean serum alkaline phosphatase (AKP) level after the implementation of the intervention to the basic value. Timepoint: At the beginning of the study and 3 month later. Method of measurement: blood sample. Gorgan University of Medical Sciences Approved 2022-12-16 Ethics committee of Golestan University of Medical Sciences Vice President of Research,Gorgan University of Medical Sciences, the beginning of Shesat Kala Rural Road,Hirkan Blvd,Basij Square Gorgan Golestan Iran (Islamic Republic of)