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IRCT20111024007892N10 IRCT 2022-04-12 Mashhad University of Medical Sciences Effect of oral calcitriol pulse therapy in comparison with oral daily calcitriol method in hemodiyalis paitients Comparison the effect of oral calcitriol pulse therapy with oral daily calcitriol method in hemodiyalis paitients 2020-12-21 anticipated 20 Complete https://irct.ir/trial/52107 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be allocated to oral calcitriol pulse therapy or oral daily calcitriol groups, by block randomization with block size of 4. In each block, patients of each group will be exist. The order of blocks will be determined randomly in oral calcitriol pulse therapy or oral daily calcitriol groups and subjects will allocated sequentially with order of admitting. Random allocation rule method was used for determination of sequences. Using non-transparent envelopes sealed with random sequences (Sequentially numbered, sealed, opaque envelopes). They are placed in order. In order to maintain the random sequence, numbering is done on the outer surface of the envelopes in the same way. Finally, the lids of the letter envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, based on the order of entry of eligible participants in the study, one of the envelopes of the letter will be opened in order and the assigned group of the participant will be revealed, Blinding description: Patients receive drugs (intervention or control groups) in closed pockets which are coded and patients are not aware of their contents. Coding will be done by one of the colleagues of the study and patient will be blind for type of drugs. 2 Secondary hyperparathyroidism of renal origin. Intervention 1: Intervention group: Oral calcitriol pulse therapy (0.75 micro gram per kilogram), three times weekly. Intervention 2: Control group: Oral daily calcitriol (0.25 micro gram per kilogram daily). No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more data
public Anoush Azarfar
Dr. Sheikh
Mashhad Iran (Islamic Republic of) 9139963185 +98 51 3726 9021 azarfara@mums.ac.ir Mashhad University of Medical Sciences scientific Anoosh Azarfar
Daneshgah street, Mashhad
Mashhad Iran (Islamic Republic of) 9139963185 +98 51 1606 1227 azarfara@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Patients with chronic kidney disease (CKD) who are under chronic hemodialysis and need to receive Calcitriol for secondary hyperparathyroidism Age less than 18 years Serum bicarbonate more than 15 mEq/L Serum albumin more than 3 g/dl Hemoglobin more than 8 g/dl 1 year 18 years Both Primary metabolic disorder Intestinal malabsorption Endocrine or liver disease Malignancies Receiving corticosteroid Receiving rhGH Hypocalcemia or hypercalcemia hypophosphatemia or hyperphosphatemia GB90.4 Secondary hyperparathyroidism of renal origin Treatment - Drugs Treatment - Drugs Intervention group: Oral calcitriol pulse therapy (0.75 micro gram per kilogram), three times weekly Control group: Oral daily calcitriol (0.25 micro gram per kilogram daily) Serum level of calcium. Timepoint: Baseline and one month after intervention. Method of measurement: laboratory measurement in blood sample. Serum level of phosphorous. Timepoint: Baseline and one month after intervention. Method of measurement: laboratory measurement in blood sample. Serum level of vitamin D. Timepoint: Baseline and one month after intervention. Method of measurement: laboratory measurement in blood sample. Serum level of alkaline phosphatase. Timepoint: Baseline and one month after intervention. Method of measurement: laboratory measurement in blood sample. Serum level of parathormone. Timepoint: Baseline and one month after intervention. Method of measurement: laboratory measurement in blood sample. Mashhad University of Medical Sciences Approved 2020-09-22 Ethical committee of Mashhad University of Medical Sciences Daneshgah Mashhad Razavi Khorasan Iran (Islamic Republic of)