The metabolic effects of multi-trace elements on parenteral nutrition for critically ill pediatric patients: a randomized controlled trial and metabolomic research

BACKGROUND: We investigated the efficacy and metabolic dose-effect of multi-trace element injection I [MTEI-(I)] for severe pediatric patients via a parallel, randomized control study. METHODS: The inclusion criteria were as follows: (I) patients who required parenteral nutrition (PN) due to various diseases, and were expected to receive PN for >5 days; (II) patients aged <18 years; (III) patients with no serious cardiac, hepatic, renal, or pulmonary dysfunction; and (IV) patients with an established central venous pathway. Enrolled patients were randomly assigned into two groups using sequentially numbered, sealed, opaque envelopes: Group A (low-dose group) received MTEI-(I) at 1 mL/kg/d, and Group B (high-dose group) received MTEI-(I) at 2 mL/kg/d, up to a maximum dose of 15 mL/d. The concentrations of manganese (Mn), copper (Cu), zinc (Zn), and selenium (Se) were detected. The following indexes were measured after 5 days of treatment (T5): β-oxidation of very-long-chain fatty acids, arginine and proline metabolism, pentose phosphate metabolism, ketone body metabolism, citric acid cycle, purine metabolism, caffeine metabolism, and pyruvate metabolism. The participants, care givers, and data analysis staff were blinded to the group assignment. RESULTS: Overall, at T5, Mn and Cu levels were decreased, while Zn and Se levels were increased. The increase of Zn levels (A: 0.170±0.479 vs. B: 0.193±0.900) and decrease of Cu levels (A: −0.240±0.382 vs. B: −0.373±0.465) of patients in Group B (n=22) were significantly higher than those in Group A (n=18). At T5, the β-oxidation of very-long-chain fatty acids, arginine and proline metabolism, pentose phosphate metabolism, ketone body metabolism, citric acid cycle, purine metabolism, caffeine metabolism, and pyruvate metabolism were variably decreased (P<0.05) in Group B compared to Group A. CONCLUSIONS: Our results suggested that the high-dose administration of MTEI-(I) is safe for severe pediatric patients, and may alleviate inflammation and antioxidation, relieve hyperactivity caused by stress, and improve tissues-based hypoxia and renal function. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2100052198.