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

• Published in: Medicine (Baltimore) Vol. 103; no. 51; p. e33170
• Main Authors: Nikoonezhad, Maryam, Zavaran Hosseini, Ahmad, Hajifathali, Abbas, Parkhideh, Sayeh, Shadnoush, Mahdi, Shakiba, Yadollah, Zahedi, Hoda
• Format: Journal Article
• Language: English
• Published: Hagerstown, MD Lippincott Williams & Wilkins 20.12.2024
• Subjects: Administration, Oral; Adolescent; Adult; Dietary Supplements; Female; Hematopoietic Stem Cell Transplantation - adverse effects; Hematopoietic Stem Cell Transplantation - methods; Humans; Immune Reconstitution; Male; Middle Aged; Randomized Controlled Trials as Topic; Study Protocol Clinical Trial; T-Lymphocytes - drug effects; T-Lymphocytes - immunology; Thymus Gland - drug effects; Thymus Gland - transplantation; Transplantation, Autologous; Young Adult; Zinc - administration & dosage; Zinc - therapeutic use; hematopoietic stem cell transplantation; immune reconstitution; thymus; T-cell; zinc
• ISSN: 1536-5964; 0025-7974; 1536-5964
• DOI: 10.1097/MD.0000000000033170

Background: Immune reconstitution is a significant factor in the success of "hematopoietic stem cell transplantation" (HSCT). Delaying the immune reconstitution increases the risk of infections and relapse after transplantation. T-cell recovery after HSCT is mainly thymus-dependent, and thymic atrophy is associated with various clinical conditions that correlate with HSCT outcomes. Thymus rejuvenation can improve immune reconstitution after transplantation. Zinc (Zn) plays a pivotal role in thymus rejuvenation. Zn deficiency can lead to thymic atrophy, which increases susceptibility to infections. Zn supplementation restores the immune system by increasing thymus output and T-cell repertoire production. We designed this protocol to investigate the effect of oral Zn supplementation on T-cell recovery in patients undergoing HSCT. Methods: Forty eligible candidates for autologous-HSCT will be selected. They will be randomly divided into Zn and placebo groups. Subsequently, they will receive 3 Zn or placebo tablets for the first 30 days post-HSCT (+1 to +30), followed by 1 pill or placebo for days (+31 to +90). The copy numbers of "recent thymic emigrants" T cells and "T cell Receptor Excision Circles" (TREC) will be assessed before and after the intervention in peripheral blood mononuclear cells (PBMCs). All patients will be followed up 365 days post-HSCT for relapse and infection. Conclusion: This clinical trial is the first to determine the efficiency of "Zn gluconate" as daily Supplementation in T cell recovery post-HSCT. If successful, an available and inexpensive drug will improve immune system reconstruction after HSCT, reduce the risk of infection, particularly viral infections, and increase patient survival.