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IRCT20211227053546N1 IRCT 2022-03-23 Shahid Beheshti University of Medical Sciences Zinc supplement effect on oxidative stress and inflammation markers in multiple myeloma patients undergo autologous hematopoietic stem cell transplantation Study of zinc supplement on oxidative stress and inflammation markers in multiple myeloma patients undergo autologous hematopoietic stem cell transplantation compared with placebo 2022-03-21 anticipated 40 Complete https://irct.ir/trial/60957 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: In this study, based on similar studies and in consultation with its researchers, the amount of "zinc" in 30 days after transplantation was selected to be 90 mg daily, Randomization description: In this randomization method, the size of the blocks is considered equal. The size of each block is 4, which includes 2 participants in the zinc group and 2 participants in the placebo group. The SNOSE method is used to perform randomization. Based on the sample size of the research, a number of envelopes were prepared with aluminum wrappers and each of the random sequences created on a card was recorded and the cards were placed in the envelopes of the letter, respectively. In order to maintain a random sequence, the envelopes were numbered in the same way on the outer surface. Finally, the lids of the letter envelopes were glued and placed in a box, respectively. At the beginning of the registration of the participants, according to the order of entry of the eligible participants, one of the envelopes will be opened in order and the assigned group of that participant will be revealed. Random sequencing was performed by SAS software version 9.4, Blinding description: This clinical trial is performed in a double-blind method, which means the patient and the principal researcher are not aware of the patient's treatment. Therefore, to maintain blindness, the randomization list is not shown to the principal researcher. A statistician prepares the randomization list. The package evaluator provides a form containing either zinc or a placebo for each patient. Zinc and placebo tablets are the same color and shape but have different ingredients. 2-3 Patients with multiple myeloma who are candidates for stem cell transplantation.. Intervention 1: Intervention group: Patients who underwent autologous HSCT receive three tablets of "gluconate zinc" (each tablet containing 30 mg zinc elemental) daily after eating main meals for first 30 days post-HSCT. Intervention 2: Control group: Patients who underwent autologous HSCT receive three tablets of "placebo" (similar to zinc supplements) daily after eating the main meals for first 30 days post-HSCT. No - There is not a plan to make this available Justification or reason for not sharing IPD is For ethical reasons, we have no plans to publish participants' data
public Nariman Mosaffa
School of medicine,Kodakyar alley, daneshjo blvd, velenjak,
Tehran Iran (Islamic Republic of) 1985717443 +98 21 2243 9970 yasamaryan@gmail.com Shahid Beheshti University of Medical Sciences scientific Maryam Nikoonezhad
Department of Immunology,School of Medicine,Tarbiat Modarres University, Nasr Bridge,Jalal Al Ahmad Street.
Tehran Iran (Islamic Republic of) 14115111 +98 21 6606 7261 maryam.nikoonezhad@gmail.com Immunology Department, Medical School, Tarbiat Modares University Iran (Islamic Republic of) Complete response to treatment Lack of underlying disease Do not get any infection in the last three months, including COVID19 Age range 40 to 60 years Patients with a history of multiple myeloma 40 years 60 years Both History of sensitivity to "zinc" oral supplement Serum levels above 200 mg/dl Patients who have taken oral supplements for three months before transplantation. People's unwillingness to collaborate in the study C90 Multiple myeloma and malignant plasma cell neoplasms Treatment - Drugs Treatment - Drugs Intervention group: Patients who underwent autologous HSCT receive three tablets of "gluconate zinc" (each tablet containing 30 mg zinc elemental) daily after eating main meals for first 30 days post-HSCT Control group: Patients who underwent autologous HSCT receive three tablets of "placebo" (similar to zinc supplements) daily after eating the main meals for first 30 days post-HSCT Determination of genes(Nrf2-INrf2(Keap1)-SOD1,2-NOX1,2) expression. Timepoint: Before hematopoietic stem cell transplantation beginning and 15,30 days after transplantation. Method of measurement: In DNA extracted from peripheral blood mononuclear cells using Real-Time-PCR. Determination of MDA-NO protein levels. Timepoint: Before hematopoietic stem cell transplantation beginning and 15,30 days after transplantation. Method of measurement: MDA assay by thiobarbituric acid method and NO assay by griess method. Determination of TNF-a cytokine. Timepoint: Before hematopoietic stem cell transplantation beginning and 15,30 days after transplantation. Method of measurement: Assay of cytokines by ELISA method. Shahid Beheshti University of Medical Sciences Approved 2022-02-09 Ethics committee of Shahid beheshti University of Medical Sciences_ Medical school Tehran - Shahid Chamran Highway Shahid Shahriari Square - Koodkiar Street - School of Medicine Tehran Tehran Iran (Islamic Republic of)