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IRCT2016052727435N2 IRCT 2016-07-08 Research Center of the Hematology and Oncology and Stem Cell Transplantation, Shariati Hospital Effects of calcitriol on the complications of hematopoietic stem cell transplantation The effects of calcitriol on the incidence rate and severity of oral mucositis in patients undergoing autologous hematopoietic stem cell transplantation: a double-blind, randomized clinical trial 2016-04-20 anticipated 80 Complete https://irct.ir/trial/22460 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive. 2-3 Condition 1: Hodgkin lymphoma. Condition 2: Non-Hodgkin lymphoma. Condition 3: Multiple myeloma. Intervention 1: Oral calcitriol 0.25 mcg pearls will be administered three times daily after receiving the conditioning regimen up to day 14 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 14 after transplantation.
public Alborz Soroush
Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences, 16 Azar Ave, Enqelab Ave
Tehran Iran (Islamic Republic of) 00 a_soroush@razi.tums.ac.ir Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences scientific Alborz Soroush
Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences, 16 Azar Ave, Enqelab Ave
Tehran Iran (Islamic Republic of) 00 a_soroush@razi.tums.ac.ir Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: age between 18 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. 18 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 14 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 14 after transplantation. Incidence rate of oral mucositis. Timepoint: Every day after receiveing conditionig regimen upto day 21 after transplantation. Method of measurement: visiting the oral cavitiy by clinical pharmacist. Severity of oral mucositis. Timepoint: Every day after receiveing conditionig regimen upto day 21 after transplantation or up to day of healing of oral mucositis. Method of measurement: scoring upon WHO grading system for severity of oral mucositis. Duration of oral mucositis condition. Timepoint: Every day after receiveing conditionig regimen upto day 21 after transplantation or up to day of healing of oral mucositis. Method of measurement: Daily visiting of the oral cavitiy by clinical pharmacist. Serum level of calcitriol. Timepoint: Before the conditioning regimen before transplantation and on day 14 after transplantation. Method of measurement: Laboratory kit of 1,25-(OH)2-D. Serum level of vitamin D. Timepoint: Before the conditioning regimen before transplantation. Method of measurement: Laboratory kit of 25-OH-D. Incidence rate of fever. Timepoint: On discharge. Method of measurement: Patient's hospital file. Lenght of fever. Timepoint: On discharge. Method of measurement: Patient's hospital file. Number od days receiveing total parentral nutrition. Timepoint: On discharge. Method of measurement: Patient's hospital file. Number of days receiveing Analgesic drugs. Timepoint: On discharge. Method of measurement: Patient's hospital file. Hypercalcemia. Timepoint: Two times weekly from transplantation up to day 14 after transplantation. Method of measurement: Level of serum calcium by laboratory. Hypocalcemia. Timepoint: Two times weekly from transplantation up to day 14 after transplantation. Method of measurement: Level of serum calcium by laboratory. Hyperphosphatemia. Timepoint: Two times weekly from transplantation up to day 14 after transplantation. Method of measurement: Level of serum phosphorus by laboratory. Hypophosphatemia. Timepoint: Two times weekly from transplantation up to day 14 after transplantation. Method of measurement: Level of serum phosphorus by laboratory. Length of hospital stay. Timepoint: On discharge. Method of measurement: Patient's hospital file. Number od days receiveing antibiotics. Timepoint: On discharge. Method of measurement: Patient's hospital file. Research Center of the Hematology and Oncology and Stem Cell Transplantation, Shariati Hospital Approved 2016-04-16 Medical Ethics Committee of Tehran University of Medical Sciences Tehran University of Medical Sciences, 16 Azar Ave, Enqelab Ave Tehran Iran (Islamic Republic of)