Study of zinc supplement on oxidative stress and inflammation markers in multiple myeloma patients undergo autologous hematopoietic stem cell transplantation compared with placebo

Determination of the level of markers and genes of oxidative stress and inflammation in patients undergoing autologous BMT under the influence of oral zinc supplementation in comparison with the placebo group

This study is a double-blind, placebo-controlled clinical trial that will be randomized by using a block design method, and study participants are randomly divided into two groups of 20 people, Zinc and Placebo. In the first month after transplantation, the patients will receive three tablets of zinc gluconate or placebo. Zinc and copper Serum levels will be measured before intervention and on days 15 and 30 after HSCT. The expression of Nrf2, INrf2 (Keap1), SOD1, SOD2, NOX1, NOX2 genes as well as the levels of TNF-α and the activity of MDA, NO enzymes will be measured to determine the effect of oral zinc supplementation on gene expression, enzyme levels and measure inflammatory and oxidative stress markers.

Eligible patients will be selected from those referred to the BMT department of Taleghani Hospital for auto-HSCT. Patients enter the study after describing the objectives of the study and filling out the consent form.

Inclusion Criteria: History of Multiple Myeloma; A complete response to treatment; Patients are candidates for AHST; have a health certificate. Exclusion Criteria: History of sensitivity to oral zinc supplement; The patients who have consumed oral zinc supplementation since three months before the transplantation; Zinc serum levels above 200mg/dl.

Group 1: Patients with a history of multiple myeloma undergoing BMT who receive placebo. Group 2: Patients with a history of multiple myeloma undergoing BMT who receive zinc.

Expression of Nrf2, INrf2 (Keap1), SOD1, SOD2, NOX1, NOX2 genes; TNF-α cytokine; Activity of MDA, NO enzymes.

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

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.

For ethical reasons, we have no plans to publish participants' data