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IRCT2015120816837N2 IRCT 2016-05-26 Research Center of the Hematology and Oncology and Stem Cell Transplantation, Shariati Hospital, Teh Effects of calcitriol on the complications of hematopoietic stem cell transplantation Effects of oral calcitriol versus placebo on hematologic and immunologic reconstitution after autologous hematopoietic stem cell transplantation: a double-blind, randomized clinical trial 2015-12-22 anticipated 60 Complete https://irct.ir/trial/15621 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive. 2-3 Condition 1: Hodgkin’s lymphoma. Condition 2: Non-Hodgkin’s lymphoma. Condition 3: Multiple myelomas. Intervention 1: Oral calcitriol 0.25 mcg pearls will be administered three times daily after receiving the conditioning regimen up to day +30 after transplantation. Intervention 2: Oral placebo pearls similarly look like the calcitriol pearls but without the active pharmaceutical ingredient will be administered three times daily after receiving the conditioning regimen up to day +30 after transplantation.
public Dr. Kosar Raoufinejad
Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences, 16 Azar Ave, Enqelab Ave, Tehran, Iran.
Tehran Iran (Islamic Republic of) +98 21 6695 4709 k-raoufinejad@razi.tums.ac.ir Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, scientific Dr. Kosar Raoufinejad
Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences, 16 Azar Ave, Enqelab Ave, Tehran, Iran.
Tehran Iran (Islamic Republic of) +98 21 6695 4709 k-raoufinejad@razi.tums.ac.ir Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran (Islamic Republic of) Inclusion criteria: age between 16 and 65 years; cases of Hodgkin’s lymphoma, non-Hodgkin’s lymphoma, or multiple myelomas; candidates for autologous peripheral blood hematopoietic stem cell transplantation. Exclusion criteria: baseline serum calcium >10.5mg/dL; baseline serum phosphorous >4.5mg/dL;history of renal stones in the past 5 years; baseline serum creatinine >1.3mg/dL; alkaline phosphatase x4 the upper limit of normal or higher; alanine transaminase >60U/L; total bilirubin >2mg/dL; sensitivity to calcitriol; disability for oral intake. 16 years 65 years Both C81 C82, C83, C90 Hodgkin lymphoma Follicular lymphoma, Non-follicular lymphoma, Mature T/NK-cell lymphomas, Other and unspecified types of non-Hodgkin lymphoma Multiple myeloma and malignant plasma cell neoplasms Treatment - Drugs Placebo Oral calcitriol 0.25 mcg pearls will be administered three times daily after receiving the conditioning regimen up to day +30 after transplantation. Oral placebo pearls similarly look like the calcitriol pearls but without the active pharmaceutical ingredient will be administered three times daily after receiving the conditioning regimen up to day +30 after transplantation. Time to absolute neutrophil engraftment. Timepoint: Every day after transplantation up to the day of absolute neutrophil engraftment. Method of measurement: Compelete Blood Count and Differential Test. Time to platelet engraftment. Timepoint: Every day after transplantation up to the day of platelet engraftment. Method of measurement: Complete Blood Count Test. Time to absolute lymphocyte recovery. Timepoint: Every day after transplantation up to the day of absolute lymphocyte recovery. Method of measurement: Compelete Blood Count and Differential Test. Absolute neutrophil count on day +15 after the transplantation. Timepoint: Day +15 after the transplantation. Method of measurement: Complete Blood Count and Differential Test. Absolute neutrophil count on day +30 after the transplantation. Timepoint: Day +30 after the transplantation. Method of measurement: Complete Blood Count and Differential Test. Platelet count on day +15 after the transplantation. Timepoint: Day +15 after the transplantation. Method of measurement: Complete Blood Count Test. Platelet count on day +30 after the transplantation. Timepoint: Day +30 after the transplantation. Method of measurement: Complete Blood Count Test. Absolute lymphocyte count on day +15 after the transplantation. Timepoint: Day +15 after the transplantation. Method of measurement: Complete Blood Count and Differential Test. Absolute lymphocyte count on day +30 after the transplantation. Timepoint: Day +30 after the transplantation. Method of measurement: Complete Blood Count and Differential Test. Hemoglobin concentration on day +15 after the transplantation. Timepoint: Day +15 after the transplantation. Method of measurement: Complete Blood Count Test. Hemoglobin concentration on day +30 after the transplantation. Timepoint: Day +30 after the transplantation. Method of measurement: Complete Blood Count Test. Absolute monocyte count on day +15 after the transplantation. Timepoint: Day +15 after the transplantation. Method of measurement: Complete Blood Count and Differential Test. Absolute monocyte count on day +30 after the transplantation. Timepoint: Day +30 after the transplantation. Method of measurement: Complete Blood Count and Differential Test. Time to leukocyte engraftment. Timepoint: Every day after transplantation up to the day of leukocyte engraftment. Method of measurement: Complete Blood Count Test. Leukocyte count on day +15 after the transplantation. Timepoint: Day +15 after the transplantation. Method of measurement: Complete Blood Count Test. Leukocyte count on day +30 after the transplantation. Timepoint: Day +30 after the transplantation. Method of measurement: Complete Blood Count Test. Number of days receiving G-CSF. Timepoint: On discharge. Method of measurement: Patient's hospital file. Number of times receiving packed red blood cells. Timepoint: On discharge. Method of measurement: Patient's hospital file. Number of times receiving platelet transfusion. Timepoint: On discharge. Method of measurement: Patient's hospital file. Length of hospital stay. Timepoint: On discharge. Method of measurement: Patient's hospital file. Incidence rate of engraftment syndrome. Timepoint: On discharge. Method of measurement: Patient's hospital file. Incidence rate of fever. Timepoint: On discharge. Method of measurement: Patient's hospital file. Length of fever. Timepoint: On discharge. Method of measurement: Patient's hospital file. Length of severe neutropenia. Timepoint: On discharge. Method of measurement: Patient's hospital file. Hypercalcemia. Timepoint: Two times weekly from transplantation up to day +30 after transplantation. Method of measurement: Level of serum calcium by laboratory. Hypocalcemia. Timepoint: Two times weekly from transplantation up to day +30 after transplantation. Method of measurement: Level of serum calcium by laboratory. Hyperphosphatemia. Timepoint: Two times weekly from transplantation up to day +30 after transplantation. Method of measurement: Level of serum phosphorus by laboratory. Hypophosphatemia. Timepoint: Two times weekly from transplantation up to day +30 after transplantation. Method of measurement: Level of serum phosphorus by laboratory. Serum level of vitamin D. Timepoint: Before the conditioning regimen before transplantation. Method of measurement: Laboratory kit of 25-OH-D. Serum level of calcitriol. Timepoint: Before the conditioning regimen before transplantation and on days +15 and +30 after transplantation. Method of measurement: Laboratory kit of 25-(OH)2-D. Long-term recovery of leukocytes. Timepoint: A median of 6 month after transplantation. Method of measurement: Complete Blood Count Test. Long-term recovery of platelets. Timepoint: A median of 6 month after transplantation. Method of measurement: Complete Blood Count Test. Long-term recovery of hemoglobin. Timepoint: A median of 6 month after transplantation. Method of measurement: Complete Blood Count Test. Relapse Incidence. Timepoint: A median of 6 month after transplantation. Method of measurement: Patient's hospital file. Disease-Free Survival. Timepoint: A median of 6 month after transplantation. Method of measurement: Patient's hospital file. Research Center of the Hematology and Oncology and Stem Cell Transplantation, Shariati Hospital, Teh Approved 2015-12-08 Medical Ethics Committee of Tehran University of Medical Sciences Tehran University of Medical Sciences, 16 Azar Ave, Enqelab Ave, Tehran, Iran Tehran Iran (Islamic Republic of)