Comparison of oral zinc supplement and placebo in improving the regeneration of T lymphocytes in patients undergoing autologous hematopoietic stem cell transplantation

Effect of oral "zinc" supplementation on T cell regeneration after autologous HSCT

This study is a double-blind, placebo-controlled clinical trial will be randomized by using a block design method, and individuals will be divided into two groups of 20 people, Zinc gluconate and Placebo. Before starting the transplant process, serum levels of zinc and copper, as well as the status of T lymphocytes, will be assessed. Then patients are randomly assigned to receive either zinc gluconate or placebo. In the first month after transplantation, the patients will receive three tablets of zinc gluconate or placebo, and then for two months, one tablet will receive daily. Serum levels of zinc and copper in patients will be measured on days 14, 30, 60, and 90 after transplantation, and T lymphocytes will be evaluated on day 90 after transplantation.

Eligible patients are selected from the clients for auto-HSCT to the BMT ward of Taleghani Hospital. After describing the study goals and obtaining patients' satisfaction, they will enter this study

Inclusion criteria: 1. Confirmed complete remission of the patient by the oncologist 2. Patients are candidates for autologous hematopoietic stem cell transplantation 3. Confirmation of the patient's heart, kidney, liver, lung, and digestive system health before hematopoietic stem cell transplantation by a specialist Exclusion criteria: 1.History of sensitivity to "zinc" oral supplement 2. The patients who have consuming Oral zinc supplementation from 3 months before the transplant 3.Serum levels above 120 U/ml

The intervention group, "Zinc Gluconate" 30 mg, and the control group, "placebo", will receive 3 tablets daily in the first month and one tablet in the second and third months after transplantation daily.

Change in the number of T cells

Patients who are candidates for HSCT will be randomly assigned to two groups of 20 people, intervention and placebo, using randomized blocks of four sizes with randomized production of 6 blocks (each block containing two A and two B). The randomization will be performed by a researcher's assistant who was not involved in the trail and will be blind to the study groups. In this step, based on the allocation sequence, bottles A or B are sequentially numbered in opaque will be sealed envelopes. They will be kept in a place with appropriate humidity and temperature. To enter the study, the researcher's assistant will be given the next numbered envelope to the patient.

In this ِduble-blind study, the researcher and participants will be blind to "zinc gluconate" and placebo and the researcher's assistant gives the supplements and placebos in the same package to the researcher. To achieve this aim, "zinc gluconate" and placebo tablets are completely similar in color, shape, and weight. The researcher's assistant collects information and provides it to the statistician who is also unaware of the study groups.