Effect of neutropenic diet with or without magnesium supplementation on inflammatory factors and outcomes of allogeneic hematopoietic stem cell transplantation in patients with acute leukemia: study protocol for a randomized clinical trial.

BACKGROUND

The management of transplantation-related complications in acute leukemia patients has become increasingly important at the bedside. Limited clinical investigations have been conducted regarding high-dose oral magnesium supplementation. In this study, the effects of oral magnesium citrate will be investigated. Magnesium's role in preventing adverse transplantation outcomes, including graft-versus-host disease (GVHD), will be examined through its inhibitory effects on inflammatory pathways and cytokine production.

METHODS

This randomized, double-blind clinical trial will be conducted at Taleghani Hospital in Tehran, Iran. Fifty patients admitted to the bone marrow transplantation ward will be enrolled based on eligibility criteria. Participants will be randomly allocated using permuted block randomization into two groups (n = 25 each): neutropenic diet with magnesium supplementation or neutropenic diet with placebo. In the intervention and placebo groups, 420 mg of magnesium citrate or placebo will be administered for 3 weeks, respectively. Patient assessment will be conducted using consent forms, general questionnaires, three-day 24-h food recalls, and laboratory tests including inflammatory factors such as Interleukin-6 (IL-6), Tumor necrosis factor-alpha (TNF-α), Erythrocyte sedimentation rate (ESR), and C-reactive protein (CRP). Statistical analysis will be performed based on the intention-to-treat principle.

DISCUSSION: This protocol aims to be one of the first to implement an oral magnesium supplementation program in a double-blind randomized controlled trial, assessing both inflammatory markers and clinical outcomes in acute leukemia patients undergoing Allo-HSCT.

TRIAL REGISTRATION: Iranian Registry of Clinical Trials. IRCT20240812062726N1. URL of trial registry record: https://irct.behdasht.gov.ir/trial/78589 . Registered on 17 September 2024.