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IRCT20150721023282N13 IRCT 2020-08-20 Esfahan University of Medical Sciences Evaluation of the effect of vitamin B6 on blood cells count in patients using linezolid Evaluation of the effect of vitamin B6 compared to placebo on the change of blood cells count in patients with chronic osteomyelitis using linezolid 2020-07-22 anticipated 70 Complete https://irct.ir/trial/50196 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Block randomization method was used in which blocks of 4 were used, Blinding description: Drug (vitamin B6) and placebo tablets will be fully similar and packaged in similar containers. The patient, the prescriber (physician), data analyst, and the laboratory personnel will be blind to the content of containers and intervention type. 2-3 drug-induced pancytopenia. Intervention 1: Intervention group: Vitamin B6 tablet (manufactured by Iran Hormone Company), 40 mg, twice daily, for 14 days. Intervention 2: Control group: Placebo tablet (manufactured by Isfahan Faculty of Pharmacy), one tablet, twice daily, for 14 days. No - There is not a plan to make this available Justification or reason for not sharing IPD is Confidentiality of patients data
public Kiana Shirani
Hezar-Jerib Ave.
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3792 7067 kianashirani@med.mui.ac.ir Esfahan University of Medical Sciences scientific Kiana Shirani
Hezar-Jerib Ave.
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3620 2086 kianashirani@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Manifestation with chronic osteomyelitis Use of linezolid 18 years no limit Both Serum level of Hgb less than 8 g/dL WBC count less than 4500 cells/mm3 Platelet count less than 50000 cells/mm3 D61.811 Other drug-induced pancytopenia Prevention Placebo Intervention group: Vitamin B6 tablet (manufactured by Iran Hormone Company), 40 mg, twice daily, for 14 days Control group: Placebo tablet (manufactured by Isfahan Faculty of Pharmacy), one tablet, twice daily, for 14 days White blood cell count. Timepoint: Before the intervention, the end of weeks 1, 2, and 3 of intervention. Method of measurement: Flow cytometry. Serum level of hemoglobin. Timepoint: Before the intervention, the end of weeks 1, 2, and 3 of intervention. Method of measurement: Flow cytometry. Blood platelet count. Timepoint: Before the intervention, the end of weeks 1, 2, and 3 of intervention. Method of measurement: Flow cytometry. Esfahan University of Medical Sciences Approved 2020-07-11 Isfahan University of Medical Sciences Hezar-Jerib Ave. Isfahan Isfehan Iran (Islamic Republic of)