Effect of magnesium supplementation on inflammatory factors and clinical outcomes of allogeneic hematopoietic stem cell transplantation in patients with acute leukemia receiving a neutropenic diet: a randomized clinical trial

Transplantation-related complications remain a major clinical challenge in patients with acute leukemia, and evidence regarding high-dose oral magnesium supplementation in this setting is limited. This study investigated the effects of oral magnesium citrate on inflammatory responses and clinical outcomes, including graft-versus-host disease (GVHD), following allogeneic hematopoietic stem cell transplantation (allo-HSCT). This randomized, double-blind, placebo-controlled clinical trial was conducted at Taleghani Hospital, Tehran, Iran, and included 45 patients aged 18-60 years undergoing bone marrow transplantation. Participants, all of whom received a standard neutropenic diet, were randomly assigned to receive a neutropenic diet with magnesium supplementation (n = 23) or placebo (n = 22). The intervention group received 420 mg/day of magnesium citrate or placebo for three weeks, with follow-up at day 100. Assessments included 24-hour dietary recalls, questionnaires, clinical evaluations, and laboratory measurements of inflammatory markers, including interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α), erythrocyte sedimentation rate (ESR), and C-reactive protein (CRP). The incidence of GVHD increased non-significantly in both groups during the 3-week intervention period but declined during follow-up, with a significantly greater reduction observed in the magnesium group by day 100. Fever incidence decreased in both groups at week 3, with a significantly larger reduction in the magnesium group 56.5% compared with placebo, 22.7%. ESR increased in both groups during the intervention period, with a greater rise observed in the placebo group, which was significant only in the crude model; however, by day 100, ESR had significantly decreased by 15% in the magnesium group and significantly increased by 13% in the placebo group across all models. TNF-α and IL-6 levels decreased in the magnesium group but increased in the placebo group at week 3, although these changes were not statistically significant over time in all models. Magnesium supplementation in allo-HSCT patients receiving a neutropenic diet may have a potential benefit, being associated with reductions in some clinical and inflammatory outcomes, including a lower incidence of GVHD and fever and reduced ESR. However, these findings were not consistent across all inflammatory markers and require confirmation in larger studies with longer intervention durations.Trial registration Iranian Registry of Clinical Trials. IRCT20240812062726N1. URL of trial registry record https//irct.behdasht.gov.ir/trial/78,589, Registration date 17 September 2024.