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IRCT20191211045701N1 IRCT 2020-06-12 Tarbiat Modares University The effect of oral "zinc" supplementation on the T cells reconstitution in patients undergoing autologous hematopoietic stem cell transplantation Comparison of oral zinc supplement and placebo effect in improving the T cells regeneration in patients undergoing autologous hematopoietic stem cell transplantation-clinical trial study 2022-06-22 anticipated 40 Complete https://irct.ir/trial/48017 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, 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 and 60 days later 30 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 4.4, Blinding description: This clinical trial is performed in a double-blind method. This means that the patient and the main researcher are not aware of the treatment that the patient receives. Therefore, in order to maintain blindness, the randomization list is not shown to the main researcher. The randomization list is prepared by a statistician. 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 with 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 and one tablet of "gluconate zinc" is taken every night before bedtime from 31 to 90 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 and one tablet of "placebo" is taken every night before bedtime from 31 to 90 days post-HSCT. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Ahmad zavaran Hosseini
Department of Immunology, School of Medicine, Tarbiat Modares University, Nasr bridge, Jalal AleAhmad,
Tehran Iran (Islamic Republic of) 14115111 +98 21 8288 3090 zavarana@modares.ac.ir Tarbiat Modares University scientific Abbas Hajifathali
Bone Marrow Transplantation ward,Taleghani hospital, Arab Street, End of Velenjak Street, Shahid Chamran Highway
Tehran Iran (Islamic Republic of) 1985717413 +98 21 2303 1657 Hajifathali@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Age range 40 to 60 years Patients with a history of multiple myeloma on complete response to treatment Patients are candidates for autologous hematopoietic stem cell transplantation Confirmation of the patient's heart, kidney, liver, lung, and digestive system health before hematopoietic stem cell transplantation by a specialist 40 years 60 years Both History of sensitivity to "zinc" oral supplement Patients who have taken oral supplements for three months before transplantation. Serum levels above 200 mg/dl C96 Other and unspecified malignant neoplasms of lymphoid, hematopoietic and related tissue 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 and one tablet of "gluconate zinc" is taken every night before bedtime from 31 to 90 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 and one tablet of "placebo" is taken every night before bedtime from 31 to 90 days post-HSCT Number of Recent Thymic Emigrant T-cells in peripheral blood mononuclear cells (PBMC). Timepoint: Before hematopoietic stem cell transplantation begging and 30, 90, 180 days after transplantation. Method of measurement: Using flow cytometry technique and specific RET T cells markers. Determination of copy number of TREC (marker of thymus output) in peripheral blood mononuclear cells (PBMC). Timepoint: Before hematopoietic stem cell transplantation begging and 30, 90, 180 days after transplantation. Method of measurement: In DNA extracted from peripheral blood mononuclear cells using Real-Time-PCR. Naive T cells number in the peripheral blood mononuclear cell population (PBMC). Timepoint: Before the hematopoietic stem cell transplantation process and 30, 90 and 180 days after transplantation. Method of measurement: Using flow cytometry techniques and T cells specific markers. Memory T cells number in the peripheral blood mononuclear cell population (PBMC). Timepoint: Before the hematopoietic stem cell transplantation process and 30, 90 and 180 days after transplantation. Method of measurement: Using flow cytometry techniques and T cells specific markers. Shahid Beheshti University of Medical Sciences Tarbiat Modares University Shahid Beheshti University of Medical Sciences Approved 2019-12-08 Ethic committee of Medical School of Tarbiat Modares University Faculty of Medicine,Tarbiat Modares University,Nasr Bridge Intersection,Jalal Al-Ahmad Highway Tehran Tehran Iran (Islamic Republic of)