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

Effect of oral "zinc" supplementation on T cells reconstitution after autologous HSCT

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, and then one tablet daily for two months. Zinc and copper Serum levels will be measured before intervention and on days 30 and 90 after HSCT. TREC copy and RTE T cell, Tn, Tm cells number will be evaluated on days 30, 90, 180 after transplantation. In order to evaluate T cells' function, patients are monitored for one year after HSCT for viral infection (CMV, EBV) and relapse.

Eligible patients will be selected from those referred to the bone marrow transplant 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 autologous hematopoietic stem cell transplantation; Without comorbidity with heart, kidney, liver, lung, and digestive system disease. Exclusion Criteria: History of sensitivity to oral zinc supplement; The patients who have consumed oral zinc supplementation from 3 months before the transplant; Zinc serum levels above 200mg/dl.

The intervention group, "Zinc Gluconate" 30 mg, and the control group, "placebo", will receive three tablets in the first thirty days post-HSCT (+1 to +30) and the following one tablet as maintenance dose will receive for sixty days (+31 to +90).

Recent Thymic Emigrant T cells number; sjTREC copies number

The designed protocol has been confirmed

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

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.