The Effect of L-Carnitine Supplementation on Some Inflammatory Biomarkers in Critically Ill Children in the Pediatric Intensive Care Unit (PICU): A Triple-Blind, Randomized Controlled Clinical Trial

Effect of L-carnitine supplementation on mean serum MDA, TAC and SOD concentration in critically ill children in the PICU. Effect of L-carnitine supplementation on mean serum CRP, ESR and IL_6 concentrations in critically ill children in the PICU. Effect of L-carnitine supplementation on mean NLR, MLR, and PLR in critically ill children in the PICU.

A phase 3, randomized, parallel-group, triple-blind, controlled clinical trial on 36 patients. Randomization will be performed using a random number table.

This study will be conducted for one week on 38 critically ill children admitted to the PICU of the Zahra Mardani Azari Pediatric Research and Educational Center in Tabriz. Before the intervention, the Prism questionnaire will be completed for the children. Blood samples will be collected before and after the intervention to assess serum MDA, CRP, TAC, ESR, MLR, and NLR levels. All patients, the intervention staff, and the investigator analyzing the results will remain blinded to the intervention type in each group.

With parental consent, critically ill children (1 month to 12 years old) expected to stay in the PICU for more than 7 days will be included in the study. Patients with liver or kidney diseases, those undergoing hemodialysis or chemotherapy, and NPO patients will be excluded from the study.

The intervention group will receive 50-100 mg/kg body weight of liquid L-carnitine daily (50 mg/kg body weight for infants under six months and 100 mg/kg body weight for older children, up to a maximum of 2 grams), while the placebo group will receive the same dose of distilled water daily for 7 days.

Reduction of oxidative stress, inflammation, and improvement of clinical status.

The minimum length of ICU stay was revised from 3 days to 7 days to ensure that participants receive the full planned intervention duration (7 days). Since the intervention is administered daily for 7 consecutive days, inclusion of patients with shorter ICU stays could lead to incomplete exposure to the intervention and introduce bias in outcome assessment. Therefore, this modification was made to maintain methodological consistency and internal validity of the trial. The sample size was adjusted by increasing the anticipated attrition rate to account for potential dropouts and incomplete data, in order to improve the precision and reliability of the study results. This led to a slight increase (from 36 to 38) in the final recruitment target.

Block randomization is used to allocate participants to each study group randomly. For this study, six blocks of six participants each have been considered, with an equal number of participants assigned to the intervention and control groups within each block. The unit of randomization in this study is individual-based, and a random number table will be used for the allocation process.

The supplements and placebos were provided by Pars Behrouzan Jam Pharmaceutical Company and labeled with two-letter codes. All patients, researchers, data analysts, and outcome assessors will remain blinded to the contents of each label until the end of the study.